HAND PIECE FOR BATTERY POWERED DRIVER

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. PRO-CODE: GXL, HXX. THE SUBJECT DEVICE HAS BEEN RECEIVED. INITIAL REPORTEROCCUPATION IS A J&J SALES REPRESENTATIVE. INVESTIGATION SUMMARY SERVICE & REPAIR HISTORY: THE PREVIOUS SERVICE EVENT FOR PART NUMBER 05.000.008 WITH LOT NUMBER(S) 004244 HAS BEEN REVIEWED. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(6) 2022 FOR PRODUCT NEEDS REPAIR. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON (B)(6) 2017 DUE TO ELECTRONIC CONTROL DAMAGE. THE PREVIOUS SERVICE CONDITION OF ELECTRONIC CONTROL DAMAGE IS NOT RELEVANT TO THE CURRENT COMPLAINED ISSUE OF PRODUCT NEEDS REPAIR. THE MANUFACTURE DATE OF THIS ITEM IS (B)(6) 2011. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE DEVICE 05.000.008 NEEDS REPAIR. THE REPAIR TECHNICIAN REPORTED THAT THE CONTACT PLATE CRACKED AND THE DEVICE DOES NOT RUN IN FAST FORWARD, FORWARD, REVERSE CONDITIONS. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE REPAIRED AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 10. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. UPDATE 31-JAN-2023 SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE DEVICE 05.000.008 NEEDS REPAIR. THE REPAIR TECHNICIAN REPORTED THAT THE CONTACT PLATE WAS CRACKED, WIRES WERE DISCOLORED, BROWN AND BLACK RESIDUE ON BARRIERS, BARRIER WAS RIPPED AND THE DEVICE DOES NOT RUN IN FAST FORWARD, FORWARD, REVERSE CONDITIONS. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHESE FINAL INSPECTION ON 11-NOV-2022 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS.. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 70. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: A SHR WAS PERFORMED ON THE SERVICEABLE DEVICE AND IT WAS FOUND THAT THE DEVICE WAS MANUFACTURED ON 7-MAY-2011. A MANUFACTURING RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE (B)(4) NO MANUFACTURING RECORD EVALUATION IS REQUIRED. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE HAND PIECE FOR BATTERY POWERED DRIVER NEEDS REPAIR. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED, PATIENT INVOLVEMENT, REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) HAND PIECE FOR BATTERY POWERED DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).