HAND PIECE FOR BATTERY POWERED DRIVER

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6)2022 THE HANDPIECE FOR BATTERY POWERED DRIVER IS NOT WORKING REVERSE. THE ISSUE WAS OBSERVED DURING WEEKLY AUDIT. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DEVICE DID NOT RUN IN REVERSE, MEMBRANE VENT WAS DIRTY AND COSMETIC TEST WAS FAILED. THIS REPORT IS FOR ONE (1) HAND PIECE FOR BATTERY POWERED DRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT PC(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 NARRATIVE: ADDITIONAL DEVICE PRODUCT CODES: (B)(4). REPORTER IS A J&J SALES REPRESENTATIVE. A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT 05.000.008, HAND PIECE FOR BATTERY POWERED DRIVER WAS NOT WORKING IN REVERSE. THE REPAIR TECHNICIAN REPORTED THE DEVICE DID NOT RUN IN REVERSE, MEMBRANE VENT WAS DIRTY AND COSMETIC TEST WAS FAILED. 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. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 05.000.008. SYNTHES LOT # 007928. SUPPLIER LOT # 007928. RELEASE TO WAREHOUSE DATE # 22 OCT 2020. SUPPLIER # TRIANGLE MANUFACTURING 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.