HAND PIECE FOR BATTERY POWERED DRIVER

Description of Event or Problem

IT WAS REPORTED THAT DURING WEEKLY AUDIT OF EQUIPMENT JUNE 15, 2022, THE HAND PIECE FOR BATTERY POWERED DRIVER MEDIUM SPEED DID NOT WORK. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE RUNS LOW IN FAST FORWARD, DOES NOT RUN IN FORWARD, REVERSE CONDITIONS, PATINA WAS FOUND BETWEEN SWITCH PLATE AND HOUSING, DISCOLORED WIRES, WHITE RESIDUE ON NOSE CONE, RED AND BROWN RESIDUE ON BARRIERS, RUST ON MOTOR. THIS REPORT IS FOR A HAND PIECE FOR BATTERY POWERED DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

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. ADDITIONAL PROCODES: GXL, HXX. FACILITY PHONE NUMBER REPORTED AS (B)(6). INITIAL REPORTER IS A SYNTHES EMPLOYEE. PART: 05.000.008. SYNTHES LOT: 006948. SUPPLIER LOT: 006948. RELEASE TO WAREHOUSE DATE: 03 OCTOBER 2017. SUPPLIER: (B)(4). NO NONCONFORMANCE REPORTS (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. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE DEVICE (B)(4), HAND PIECE FOR BATTERY POWERED DRIVER MEDIUM SPEED DOES NOT WORK. THE REPAIR TECHNICIAN REPORTED THAT DEVICE RUNS LOW IN FAST FORWARD, DOES NOT RUN IN FORWARD, REVERSE CONDITIONS, PATINA WAS FOUND BETWEEN SWITCH PLATE AND HOUSING, DISCOLORED WIRES, WHITE RESIDUE ON NOSE CONE, RED AND BROWN RESIDUE ON BARRIERS, RUST ON MOTOR. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: CIRCUIT BOARD, SHRINK TUBING, MOTOR/GEARHEAD, CAM SCREW, MEMBRANE SWITCH/FLEX CIRCUIT, HAND PIECE FOR BATTERY AND ALL APPLICABLE COMPONENTS. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION, AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. FINALIZED SERVICE RECORD WILL BE ARCHIVED. 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.