BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE BATTERY POWERED DRIVER

    MDR report key: 20248805 · Received September 18, 2024

    Report

    Report Number
    8030965-2024-11728
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 7, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    10887587024585
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. H6: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT IT WAS REPORTED THAT ON (B)(6) 2024, THE HAND PIECE FOR BATTERY POWERED DRIVER BUTTONS MALFUNCTIONING. THE REPAIR TECHNICIAN REPORTED THAT COSMETICS TASTED FAILED, DISCOLORED PINS, CRACKED CONTACT PLATE, MOTOR RUN INTERMITTENT IN REVERSE CONDITION, DISCOLORED WIRES, DEBRIS ON INTERNAL COMPONENTS, DAMAGED SWITCH PLATE, RUST ON MOTOR, RUSTED AND SCRATCHED NOSE CONE. THE CAUSE OF THE ISSUE IS IMPROPER MAINTENANCE. 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 NOT 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 REVIEW (DHR): PART # 05.000.008, SYNTHES LOT # 002403, SUPPLIER LOT # 6030057, RELEASE TO WAREHOUSE DATE: 19 NOV 2008, MANUFACTURING SITE: 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024 , THE HAND PIECE FOR BATTERY POWERED DRIVER BUTTONS WERE MALFUNCTIONING. THE ISSUE WAS OBSERVED DURING ROUTINE FIELD MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. UPON INSPECTION OF THE RETURNED DEVICE, FOREIGN SUBSTANCE WAS NOTED ON THE ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343190 HANDLE BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 002403 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown