BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHUCK WITH KEY F/BPL

    MDR report key: 19664708 · Received July 3, 2024

    Report

    Report Number
    8030965-2024-08247
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 3, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    UDI-DI
    07611819138667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, IT WAS DETERMINED THAT THE REPORTED CONDITION THAT THE DEVICE WAS BROKEN WAS NOT CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, DURING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS FROZEN/WOULD NOT MOVE-CHICK SEIZED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE TRACED TO USER, WHICH IS USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-SURGERY IT WAS DISCOVERED THAT THE CHUCK WITH KEY DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE WAS FROZEN/WOULD NOT MOVE-CHUCK SEIZED AND COLOR BAND WAS CHIPPING/FADING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION AND CHECK DRILL CHUCK FUNCTION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551411 CHUCK WITH KEY F/BPL MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES GMBH 8081760 07611819138667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown