HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL
Report
- Report Number
- 2939274-2020-01901
- Event Type
- Malfunction
- Date Received
- April 17, 2020
- Report Date
- March 23, 2020
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HWX
- UDI-DI
- 10886982187147
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H4, H6: PART NUMBER: 310.95, LOT NUMBER: 8803278, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: FEBRUARY 11, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE HANDLE WITH QUICK COUPLING, STAINLESS STEEL (P/N: 310.95, LOT #: 8803278) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, DEEP SCRATCHES WERE OBSERVED ON THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. FUNCTIONAL TESTING: THE FUNCTIONAL TESTING WAS NOT PERFORMED AS THE DEVICE WAS RETURNED BY ITSELF. DURING TESTING AT SERVICE AND REPAIR, THE DEVICE FAILED TO OPERATE SMOOTH AND NON-BINDING THROUGH THE ENTIRE RANGE OF OPERATION. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? UNABLE TO PERFORM SERVICE AND REPAIR EVALUATION: VETERINARY COMPLAINT: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE WITH MINI QUICK COUPLING WAS NOT GRIPPING THE DRILL BITS AND SCREWDRIVER TIPS. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED FOR THE INSTRUMENT OPERATION TO BE SMOOTH OR NON-BINDING. THE SUPPLIER UNABLE TO REPAIR IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE INTERNAL DIAMETER OF THE CANNULATION IN THE COUPLING WAS MEASURED TO BE 2.37 MM (GAGE PIN: GP32). THIS IS WITHIN THE SPECIFICATION OF 2.36 H8 MM (2.36 MM +0.014 MM/-0 MM (ISO 286-2). FURTHER DIMENSIONAL INSPECTION TO CAPTURE FUNCTIONALITY CANNOT BE PERFORMED AS THE INTERNAL COMPONENTS WERE INACCESSIBLE WITHOUT THE DESTRUCTION OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED HANDPIECE , CMF , SMW. COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED FAILED TO OPERATE SMOOTH AND NON-BINDING. HENCE CONFIRMING THE COMPLAINT. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS CONFIRMED FOR THE HANDLE WITH QUICK COUPLING, STAINLESS STEEL (P/N: 310.95, LOT #: 8803278). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO THE BINDING OF THE COLLAR. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6: THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
CONCOMITANT DEVICE REPORTED: SCREWDRIVER SHAFT (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), DRILL BITS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN).
DEVICE USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE HANDLE WITH MINI QUICK COUPLING WAS NOT GRIPPING THE DRILL BITS AND SCREWDRIVER TIPS. IT WAS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WAS SURGICAL DELAY OF TEN (10) MINUTES. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A VETERINARY COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434943 | HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL | TAP,BONE | HWX | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 310.95 | 8803278 | 10886982187147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK - DRILL BITS: TRAUMA| UNK - SCREWDRIVERS: SHAFTS |