BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 22878721 · Received August 22, 2025

    Report

    Report Number
    8030965-2025-08672
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    10887587024585
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. ADDITIONAL NARRATIVE: H6: PRODUCT INVESTIGATION: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE ITEM -05.000.008 - IT STOPPED WORKING. THE REPAIR TECHNICIAN REPORTED THAT THE DEVICE HAD HOUSING & PROTECTOR/SHIELD HAVING FOREIGN SUBSTANCES, RUST ON MOTOR, CRACKED IN PLATE, CIRCUIT BOARD HAD BUTTON FAILURE, DISCOLORED/FADING IN CABLE, ELECTRICAL. THE CAUSE OF THE ISSUE IS IMPROPER MAINTENANCE. THE ITEM WILL BE REPAIRED, PUT THROUGH 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. DHR: PART # 05.000.008 SYNTHES LOT # 003816 SUPPLIER LOT # 003816 RELEASE TO WAREHOUSE DATE: 04 OCT 2010 SUPPLIER: (B)(4). NO NCR'S 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 THE ITEM HAND PIECE FOR BATTERY POWERED DRIVER STOPPED WORKING. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2667233 HAND PIECE FOR BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown