HAND PIECE FOR BATTERY POWERED DRIVER

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE HAND PIECE FOR BATTERY POWERED DRIVER WAS NOT FUNCTIONING. ANOTHER DEVICE WAS FOUND IN ANOTHER TRAY. THERE WAS NO REPORTED PATIENT CONSEQUENCE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE RUNS LOW IN FAST FORWARD AND REVERSE CONDITIONS, THE MEMBRANE VENT WAS DIRTY, AND THE CONTACT PLATE WAS CRACKED. 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. REPORTER IS A SYNTHES EMPLOYEE. PART: 05.000.008. SYNTHES LOT: 003334. SUPPLIER LOT: 003334. RELEASE TO WAREHOUSE DATE: 04 AUGUST 2010. SUPPLIER: TRIANGLE MANUFACTURING. 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: IT WAS REPORTED THAT THE DEVICE 05.000.008, HAND PIECE FOR BATTERY POWERED DRIVER WAS NOT FUNCTIONING DURING CASE, FOUND ONE THAT WORKS IN ANOTHER TRAY. THE ISSUE WAS OBSERVED DURING SURGERY. THE REPAIR TECHNICIAN REPORTED THAT THE DEVICE RUNS LOW IN FAST FORWARD AND REVERSE CONDITIONS, MEMBRANE VENT WAS DIRTY, CONTACT PLATE WAS CRACKED. 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. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE , A FOLLOW-UP WILL BE FILED AS APPROPRIATE.