BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES

    MDR report key: 3981394 · Received August 5, 2014

    Report

    Report Number
    3009450871-2014-10310
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SERVICE HISTORY REVIEW OF THE DEVICE HAS BEEN PERFORMED. THE REVIEW INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED DURING THE PAST 6 MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE DEVICE FAILURE REPORTED BY THE CUSTOMER COULD BE CONFIRMED. THE SERVICE HISTORY REVIEW SHOWS NO PREVIOUS SERVICE CONDITIONS RELEVANT TO THE CURRENT COMPLAINT ISSUE. THE SERVICE TECHNICIAN NOTED THE ACTION TAKEN AS REPAIR. THE DEVICE HAS BEEN SERVICED AND FUNCTIONAL TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH THE SERVICE & REPAIR PROCEDURE. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE SERVICE TECHNICIAN IDENTIFIED THE FAILURE CODE AS COUPLING TOOL SIDE WORN OUT. THE SERVICE TECHNICIAN IDENTIFIED THE PROBABLE ROOT CAUSE AS NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED THE CUSTOMER. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE COUPLING DOES NOT FUNCTION, IT DOES NOT HOLD THE WIRE IN PLACE WHEN IN USE. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458043 QUICK COUPLING FOR K-WIRES INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1