HAND PIECE FOR BATTERY POWERED DRIVER

Description of Event or Problem

IT WAS REPORTED THAT THE HANDPIECE FOR BATTERY POWERED DRIVER DOESN'T MOVE FORWARD. THE ISSUE WAS OBSERVED DURING SURGERY. NO DELAYS OR INJURIES. NO FURTHER INFORMATION WAS PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DEVICE DOES NOT RUN IN REVERSE MODE, BROKEN DIRTY MEMBRANE VENT, DISCOLORED WIRES, RUST ON MOTOR, BROWN RESIDUE ON BARRIERS, GRINDING BEARINGS. THIS REPORT IS FOR ONE (1) HAND PIECE FOR BATTERY POWERED DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODES: GXL, HXX. REPORTER IS A J&J SALES REPRESENTATIVE. A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE 05.000.008 DOESN'T MOVE FORWARD. THE REPAIR TECHNICIAN REPORTED DEVICE DOES NOT RUN IN REVERSE MODE, BROKEN DIRTY MEMBRANE VENT, DISCOLORED WIRES, RUST ON MOTOR, BROWN RESIDUE ON BARRIERS, GRINDING BEARINGS. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WAS REPAIRED AND PASSED SYNTHES FINAL INSPECTION 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 # 007518. SUPPLIER LOT # 007518. RELEASE TO WAREHOUSE DATE: 10 APR 2019. SUPPLIER: (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.