HANDLE BATTERY POWERED DRIVER

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2022 MULTIPLE DRIVERS WERE TESTED, THE OPERATING FUNCTIONS ON THE DEVICES ARE INCONSISTENT OR NOT WORKING. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR HANDLE BATTERY POWERED DRIVER.

Additional Manufacturer Narrative

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. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT 05.000.008, HAND PIECE FOR BATTERY POWERED DRIVER WAS NOT WORKING. THE REPAIR TECHNICIAN REPORTED THE DEVICE DID NOT RUN IN FAST FORWARD, FORWARD, OR REVERSE, WIRES WERE DISCOLORED AND BROWN RESIDUE WAS PRESENT ON BARRIERS. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: CIRCUIT BOARD, PFHS, MOTOR/GEARHEAD, MEMBRANE SWITCH/FLEX CIRCUIT, CAM SCREW, BEARING AND ROTARY SEAL DRIVE SHAFT AND SHRINK TUBING. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 01-SEP-2022 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 30. 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: PART # 05.000.008, SYNTHES LOT # 5543051, SUPPLIER LOT # N/A, RELEASE TO WAREHOUSE DATE: 15 APR 2014, MANUFACTURED BY: SYNTHES (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.