BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE BATTERY POWERED DRIVER

    MDR report key: 21524650 · Received March 5, 2025

    Report

    Report Number
    8030965-2025-02123
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    January 1, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    7611819890084
    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. ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE ITEM HAND PIECE FOR BATTERY POWERED DRIVER ARE NOT WORKING PROPERLY. THE REPAIR TECHNICIAN REPORTED THAT CONTACT PLATE WAS CRACKED, WIRE AND VENT WAS DISCOLORED, AND DEBRIS WAS PRESENT ON BARRIERS. DEVICE RUNS INTERMITTENTLY AT FORWARD AND FAST-FORWARD. ALSO, COSMETIC TEST WAS FAILED TOO. THE CAUSE OF THE ISSUE IS FAULTY PARTS. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 7-FEB-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: PRODUCT CODE: : 05.000.008, LOT NUMBER : 001368, RELEASE TO WAREHOUSE DATE : 26.FEB.2007, EXPIRATION DATE : NA. SUPPLIER: NA. MANUFACTURING SITE: JJMSZ PLANT FOR STK & N-STK . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 ARE NOT WORKING PROPERLY. IT IS UNKNOWN WHEN THE INCIDENT WAS OBSERVED. PATIENT INVOLVEMENT UNKNOWN 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
    448923 HANDLE BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 7611819890084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown