BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 22054094 · Received May 20, 2025

    Report

    Report Number
    8030965-2025-05027
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    January 1, 2025
    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

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: H3, H6 INVESTIGATION SUMMARY: SERVICE AND REPAIR EVALUATION: THE REPAIR TECHNICIAN REPORTED DAMAGED VENT, DISCOLORED PIN, CRACKED CONTACT PLATE, COSMETIC TEST FAILED, FAST FORWARD, FORWARD, REVERES FUNCTION TEST LOW, DISCOURSED WIRE, DEBRIS ON BARRIER AND RUST ON MOTOR. THE CAUSE OF THE ISSUE IS IMPROPER MAINTENANCE. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED MEDTECH ORTHOPAEDICS 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. DEVICE HISTORY REVIEW (DHR): PART # 05.000.008 SYNTHES LOT # 6232779 SUPPLIER LOT # 003151 RELEASE TO WAREHOUSE DATE: 25.SEP.2009 . 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HANDLE BATTERY POWERED DRIVER HAD A SLOW/WEAK MOTOR ON AN UNKNOWN DATE. THE ISSUE WAS OBSERVED DURING ROUTINE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182044 HAND PIECE FOR BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 003151 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown