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Others titles
- Adverse Events Total Hip and Direct Anterior Replacement 2018
- Adverse Events Replacement Precautions and Total Hip Replacement 2018
- Adverse Events Knee Replacement and Total Hip Replacement 2018
- Adverse Events Total Knee Replacement and Total Hip Replacement 2018
Keywords
- Direct Anterior
- Replacement Precautions
- Knee Replacement
- Total Knee Replacement
- Direct Anterior Knee Replacement
- Medical Devices
Adverse Events Total Hip Replacement 2018
This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2018 through December 31, 2018.
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Description
This dataset includes reports submitted to the Food and Drug Administration (FDA) from January 01, 2018 through December 31, 2018. The reports are submitted to the FDA by both mandatory and voluntary reporters. Mandatory reports are provided by manufacturers, importers, and device user facilities, such as hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Voluntary reports are provided by health care professionals, patients and consumers. The reports include suspected device-associated deaths, serious injuries and malfunctions. The FDA uses the reports to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of the products.
Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The Manufacturer and User Facility Device Experience Database (MAUDE) database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
About this Dataset
Data Info
| Date Created | 2018-01-01 |
|---|---|
| Last Modified | 2018-12-31 |
| Version | 2018-12-31 |
| Update Frequency |
Annual |
| Temporal Coverage |
2018-01-01 to 2018-12-31 |
| Spatial Coverage |
United States |
| Source | John Snow Labs; United States Food and Drug Administration; |
| Source License URL | |
| Source License Requirements |
N/A |
| Source Citation |
N/A |
| Keywords | Direct Anterior, Replacement Precautions, Knee Replacement, Total Knee Replacement, Direct Anterior Knee Replacement, Medical Devices |
| Other Titles | Adverse Events Total Hip and Direct Anterior Replacement 2018, Adverse Events Replacement Precautions and Total Hip Replacement 2018, Adverse Events Knee Replacement and Total Hip Replacement 2018, Adverse Events Total Knee Replacement and Total Hip Replacement 2018 |
Data Fields
| Name | Description | Type | Constraints |
|---|---|---|---|
| Web_Address | Website link to adverse event report | string | - |
| Report_Number | Adverse event report number | string | - |
| Event_Date | Date the event occurred | date | - |
| Event_Type | Type of event: Injury, Malfunction, or Death | string | - |
| Manufacturer | Manufacturer of the device that caused the adverse event | string | - |
| Date_Received | Date the adverse event report was received by the Food and Drug Administration | date | - |
| Product_Code | Classification product code used by the Food and Drug Administration | string | - |
| Brand_Name | Market name of the device | string | - |
| Event_Description | Narrative of the adverse event | string | - |
Data Preview
| Web Address | Report Number | Event Date | Event Type | Manufacturer | Date Received | Product Code | Brand Name | Event Description |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8202415&pc=HBE | 1030489-2018-01709 | 2018-11-30 | Injury | MEDTRONIC SOFAMOR DANEK USA, INC | 2018-12-28 | HBE | POWEREASE INSTRUMENTS | IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION PROCEDURE. DURING THE SURGERY, THE SCREW DRIVER TIP BROKE OFF IN THE SCREW WHEN THE SCREW WAS ADVANCED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8203218&pc=HBE | 1045254-2018-00745 | Injury | MEDTRONIC XOMED INC. | 2018-12-28 | HBE | IPC® FOOTPEDAL - LEGEND EHS | A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE FOOT PEDAL MALFUNCTIONED AND CAUSED PATIENT HARM DURING THE PROCEDURE. THE HCP ALSO NOTED THAT THE PERFORATOR KEPT SPINNING WITH NO PRESSURE ON THE FOOT PEDAL. Manufacturer Narrative: SUBMITTING THIS REGULATORY REPORT IN REFERENCE TO MEDWATCH FORM #: 1625507-2018-00080. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. | |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8203621&pc=HBE | 1045254-2018-00748 | 2018-12-02 | Malfunction | MEDTRONIC XOMED INC. | 2018-12-28 | HBE | XPS® CLEARVIEW - LEGEND TOOL | A REGULATORY BODY REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE HEAD OF THE DEVICE WAS BROKEN WHEN THE BOX WAS OPENED PRIOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. Manufacturer Narrative: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8190078&pc=HBE | 1045834-2018-52507 | 2018-11-08 | Malfunction | DEPUY SYNTHES PRODUCTS LLC | 2018-12-21 | HBE | 4MM COARSE DIAMOND BALL, 15 CM | IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE CUTTER DEVICE WAS STUCK INSIDE THE ATTACHMENT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT A PIECE OF THE CUTTER DEVICE WAS BROKEN OFF AND STUCK INSIDE THE ATTACHMENT DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. QUALITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ATTACHMENT DEVICE WAS TAKEN APART AND IT WAS NOTED THAT EXCESSIVE FORCE WAS APPLIED, AND MEDICAL DEBRIS WAS OBSERVED IN THE LOCKING MECHANISM ASSEMBLY WHICH PREVENTED THE LOCK TABS FROM RELEASING THE CUTTER DEVICE WHICH IN TURN, CAUSED THE FAILURE. THE PIECE OF THE CUTTER DEVICE WAS EXAMINED USING 25X MAGNIFICATION AND RECHECKED ON AN OPTICAL COMPARATOR. A FULL ASSESSMENT OF THE DEVICE COULD NOT BE PERFORMED DUE TO THE CONDITION OF WHICH THE CUTTER DEVICE WAS RECEIVED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191104&pc=HBE | 1045834-2018-52499 | 2018-12-01 | Injury | DEPUY SYNTHES PRODUCTS LLC | 2018-12-21 | HBE | COMPACT SPEED REDUCER, 60:1 | THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING TREPANATION OF THE SKULL IT WAS OBSERVED THAT TREPAN DEVICE WOULD NOT STOP SPINNING AND THE TREPAN HEAD WAS DISCONNECTED FROM THE COMPACT SPEED REDUCER DEVICE AND THE MOTOR DEVICE AND BECAME STUCK IN THE PATIENT¿S HEAD. IT WAS REPORTED THAT THE MOTOR DEVICE DID NOT DISENGAGE. IT WAS REPORTED THAT THERE WAS A GREATER THAN 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY REMOVING THE TREPAN HEAD MANUALLY. IT WAS REPORTED THAT THERE WAS UNKNOWN, SEVERE PATIENT CONSEQUENCES. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: ADDITIONAL NARRATIVE: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPON FURTHER INVESTIGATION IT WAS NOTED THAT TWO CRANIOTOME DEVICES AND TWO ATTACHMENT DEVICES WERE USED IN THE PROCEDURE. THERE WAS NO REPORT OF A REPORTABLE MALFUNCTION WITH THESE CONCOMITANT PRODUCTS. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191123&pc=HBE | 1045834-2018-52502 | 2018-11-27 | Injury | DEPUY SYNTHES PRODUCTS LLC | 2018-12-21 | HBE | COMPACT SPEED REDUCER, 60:1 | THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING TREPANATION OF THE SKULL IT WAS OBSERVED THAT TREPAN DEVICE WOULD NOT STOP SPINNING AND THE TREPAN HEAD WAS DISCONNECTED FROM THE COMPACT SPEED REDUCER DEVICE AND THE MOTOR DEVICE AND BECAME STUCK IN THE PATIENT¿S HEAD. IT WAS REPORTED THAT THE DURA MATTER WAS TOUCHED. IT WAS REPORTED THAT THE MOTOR DEVICE DID NOT DISENGAGE. IT WAS REPORTED THAT THERE WAS A GREATER THAN 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT AN UNSPECIFIED SPARE DEVICE AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY REMOVING THE TREPAN HEAD MANUALLY. IT WAS REPORTED THAT BLEEDING WAS STOPPED WITH COAGULATION. IT WAS REPORTED THAT THE INTERVENTION WENT WELL, WITH NO CONSEQUENCE TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: ADDITIONAL NARRATIVE: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPON FURTHER INVESTIGATION IT WAS NOTED THAT TWO CRANIOTOME DEVICES AND TWO ATTACHMENT DEVICES WERE USED IN THE PROCEDURE. THERE WAS NO REPORT OF A REPORTABLE MALFUNCTION WITH THESE CONCOMITANT PRODUCTS. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191298&pc=HBE | 1045834-2018-52504 | 2018-11-30 | Injury | DEPUY SYNTHES PRODUCTS LLC | 2018-12-21 | HBE | COMPACT SPEED REDUCER, 60:1 | THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING TREPANATION OF THE SKULL IT WAS OBSERVED THAT TREPHINE DEVICE WOULD NOT STOP SPINNING AND THE TREPHINE HEAD DISCONNECTED FROM THE COMPACT SPEED REDUCER DEVICE AND THE MOTOR DEVICE AND BECAME STUCK IN THE PATIENT¿S HEAD. IT WAS FURTHER REPORTED THAT THE MOTOR DEVICE DID NOT DISENGAGE. IT WAS REPORTED THAT THERE WAS A GREATER THAN 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY REMOVING THE TREPAN HEAD MANUALLY. IT WAS REPORTED THAT DUE TO THE PERFORATION IN THE MENINGES AND THE BRAIN, CAUSED BY THE TREPHINE, LOCAL HEMOSTASIS AND FILLING THE GAP WITH WATERPROOF TISSUE WERE REQUIRED. MULTIPLE ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN PROVIDED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191341&pc=HBE | 1045834-2018-52506 | 2018-12-07 | Injury | DEPUY SYNTHES PRODUCTS LLC | 2018-12-21 | HBE | COMPACT SPEED REDUCER, 60:1 | THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IT WAS REPORTED FROM (B)(6) THAT DURING TREPANATION OF THE SKULL IT WAS OBSERVED THAT WHILE MAKING THE FIRST HOLE IN THE SKULL, THE TREPHINE DEVICE WOULD NOT STOP TURNING AND THE TREPAN HEAD DISCONNECTED FROM THE COMPACT SPEED REDUCER DEVICE AND THE MOTOR DEVICE AND BECAME STUCK IN THE PATIENT¿S HEAD. IT WAS FURTHER REPORTED THAT THE MOTOR DEVICE DID NOT DISENGAGE. IT WAS REPORTED THAT THE DEVICE REACHED THE DURA MATTER WHICH CAUSED MAJOR BLEEDING. IT WAS REPORTED THAT THERE WAS GREATER THAN A 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY REMOVING THE TREPHINE HEAD MANUALLY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED WITH A BLOOD TRANSFUSION. THE PATIENT'S STATUS IS UNKNOWN. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT OUTCOME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191389&pc=HBE | 1045834-2018-52509 | 2018-06-07 | Injury | DEPUY SYNTHES PRODUCTS LLC | 2018-12-21 | HBE | COMPACT SPEED REDUCER, 60:1 | THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING TREPANATION OF THE SKULL IT WAS OBSERVED THAT TREPHINE DEVICE (CODMAN) WOULD NOT STOP SPINNING AND THE TREPAN HEAD DISCONNECTED FROM THE COMPACT SPEED REDUCER DEVICE AND THE MOTOR DEVICE AND PENETRATED INTO THE PATIENT'S BRAIN. IT WAS FURTHER REPORTED THAT THE MOTOR DEVICE DID NOT DISENGAGE. IT WAS REPORTED THAT THERE WAS A GREATER THAN 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY REMOVING THE TREPAN HEAD MANUALLY AND GAINING HEMOSTASIS ON THE CEREBRAL CORTEX. IT WAS REPORTED THAT THERE WAS A CEREBRAL CONTUSION AT THE SURGICAL SITE, AND THE PATIENT HAD SOME LANGUAGE DISORDERS POST-OPERATIVELY WHICH MAY HAVE BEEN RELATED TO A TUMOR THAT WAS BEING OPERATED ON. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: ADDITIONAL NARRATIVE: CORRECTION: IT WAS DOCUMENTED IN THE INITIAL MEDWATCH REPORT THAT THE DATE OF MANUFACTURE (DOM) WAS ((B)(4) 2015). THE DOM ((B)(4) 2015) HAS BEEN UPDATED TO REFLECT THE DATE THE DEVICE WAS MANUFACTURED. THE UNIQUE IDENTIFIER (UDI) HAS BEEN UPDATED ACCORDINGLY. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE COMPACT SPEED REDUCER DEVICE WAS EVALUATED AND THE REPORTED CONDITION THAT THE THAT THE TREPAN HEAD WAS DISCONNECTED FROM THE COMPACT SPEED REDUCER COULD NOT BE CONFIRMED. AN ASSESSMENT WAS PERFORMED AND THE DEVICE PASSED ALL ASSESSMENTS. DURING DEVICE EVALUATION, THE ACTUAL COMPACT SPEED REDUCER DEVICE AND THE MOTOR DEVICE WERE FUNCTIONALLY TESTED WITH A CODMAN PERFORATOR DEVICE, PERFORMING FIVE (5) PERFORATIONS. IN EACH OF THE PERFORATIONS, IT WAS OBSERVED THAT THE PERFORATOR SUCCESSFULLY DECLUTCHED (STOPPED SPINNING) WHEN THE INNER BURR PENETRATED THE UNDERLYING SURFACE. IT WAS FURTHER OBSERVED THAT THE PERFORATOR WAS SUCCESSFULLY REMOVED FROM THE WOOD MEDIA AFTER EACH PERFORATION BY PULLING ON THE SPEED REDUCER DEVICE. THEREFORE, THE REPORTED CONDITION WAS NOT DUPLICATED OR CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. A REVIEW OF THE SERVICE HISTORY RECORD INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED FOR A SERVICE CONDITION THAT IS RELEVANT TO THE CURRENT REPORTED CONDITION IN THE LAST YEAR; THE REVIEW INDICATES THE DEVICE HAS LAST BEEN RETURNED OVER A YEAR AGO. THE REVIEW INDICATES THERE WERE NO ABNORMALITIES OR NON-CONFORMANCES IDENTIFIED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191489&pc=HBE | 1045834-2018-52511 | 2018-10-23 | Injury | DEPUY SYNTHES PRODUCTS LLC | 2018-12-21 | HBE | COMPACT SPEED REDUCER, 60:1 | THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING TREPANATION OF THE SKULL IT WAS OBSERVED THAT WHILE MAKING THE SECOND HOLE IN THE SKULL, THE TREPHINE DEVICE WOULD NOT STOP TURNING AND THE TREPAN HEAD DISCONNECTED FROM THE COMPACT SPEED REDUCER DEVICE AND THE MOTOR DEVICE AND BECAME STUCK IN THE PATIENT¿S HEAD. IT WAS FURTHER REPORTED THAT THE MOTOR DEVICE DID NOT DISENGAGE. IT WAS REPORTED THAT THE DEVICE PENETRATED INTO THE PATIENT¿S BRAIN RESULTING IN A LEFT FRONTAL CONTUSION. IT WAS REPORTED THAT THERE WERE NO PROBLEMS OBSERVED WHILE MAKING THE FIRST HOLE. IT WAS REPORTED THAT THERE WAS A GREATER THAN 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY REMOVING THE TREPHINE HEAD MANUALLY AND THERE WAS NO CLINICAL CONSEQUENCE FOR THE PATIENT DUE TO THE MALFUNCTION OCCURRING IN NON-FUNCTIONAL AREA. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED HOME WITHOUT INJURY OR CONSEQUENCE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: ADDITIONAL NARRATIVE: CORRECTED DATA:THE DEVICE MANUFACTURE DATE WAS REPORTED AS MAY 3, 2015 IN THE INITIAL MEDWATCH REPORT. THIS HAS BEEN UPDATED TO MARCH 9, 2015. THE UDI HAS BEEN UPDATED ACCORDINGLY. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPON FURTHER INVESTIGATION IT WAS NOTED THAT TWO CRANIOTOME DEVICES AND TWO ATTACHMENT DEVICES WERE USED IN THE PROCEDURE. THERE WAS NO REPORT OF A REPORTABLE MALFUNCTION WITH THESE CONCOMITANT PRODUCTS. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE COMPACT SPEED REDUCER DEVICE WAS EVALUATED AND THE REPORTED CONDITION THAT THE THAT THE TREPAN HEAD WAS DISCONNECTED FROM THE COMPACT SPEED REDUCER COULD NOT BE CONFIRMED. AN ASSESSMENT WAS PERFORMED AND THE DEVICE MET ALL MANUFACTURE'S SPECIFICATIONS, NO PROBLEM FOUND. DURING DEVICE EVALUATION, THE ACTUAL COMPACT SPEED REDUCER DEVICE AND THE MOTOR DEVICE WERE FUNCTIONALLY TESTED WITH A CODMAN PERFORATOR DEVICE, PERFORMING FIVE (5) PERFORATIONS. IN EACH OF THE PERFORATIONS, IT WAS OBSERVED THAT THE PERFORATOR SUCCESSFULLY DECLUTCHED (STOPPED SPINNING) WHEN THE INNER BURR PENETRATED THE UNDERLYING SURFACE. IT WAS FURTHER OBSERVED THAT THE PERFORATOR WAS SUCCESSFULLY REMOVED FROM THE WOOD MEDIA AFTER EACH PERFORATION BY PULLING ON THE SPEED REDUCER DEVICE. THEREFORE, THE REPORTED CONDITION WAS NOT DUPLICATED OR CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. A REVIEW OF THE SERVICE HISTORY RECORD INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED FOR A SERVICE CONDITION THAT IS RELEVANT TO THE CURRENT REPORTED CONDITION IN THE LAST YEAR; THE REVIEW INDICATES THE DEVICE HAS LAST BEEN RETURNED OVER A YEAR AGO. THE REVIEW INDICATES THERE WERE NO ABNORMALITIES OR NON-CONFORMANCES IDENTIFIED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. |