BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE BATTERY POWERED DRIVER

    MDR report key: 22166670 · Received June 9, 2025

    Report

    Report Number
    8030965-2025-05736
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    April 11, 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

    J&J MEDTECH IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH J&J MEDTECH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, J&J MEDTECH OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, J&J MEDTECH, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INVESTIGATION SUMMARY SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT ON (B)(6) 2025 THE PRODUCT 05.000.008 DID NOT WORK AT ALL. AFTER CHANGING THE BATTERY STILL IT DID NOT WORK. THE ISSUE WAS OBSERVED DURING SURGERY. THE CAUSE OF THE ISSUE IS IMPROPER MAINTENANCE. THE REPAIR TECHNICIAN REPORTED THAT INTERMITTENT RUNNING FOR FORWARD, FAST FORWARD & REVERSE, CRACK CONTACT PLATE, DEBRIS ON BARRIERS, RUST ON MOTOR, DISCOLORED WIRE AND DISCOLORED VENT. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON (B)(6) 2025 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN MDS&R. 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 PART # 05.000.008, SYNTHES LOT # 003002, SUPPLIER LOT # 6193618, RELEASE TO WAREHOUSE DATE: 29 JUL 2009, 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 ON (B)(6) 2025 THE PRODUCT 05.000.008 DID NOT WORK AT ALL. AFTER CHANGING THE BATTERY STILL IT DID NOT WORK. THE ISSUE WAS OBSERVED DURING SURGERY. THERE WAS NO DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355944 HANDLE BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown