BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE QUICK COUPLING

    MDR report key: 3101356 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02151
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. VISUAL INVESTIGATION SHOWS DAMAGE AND MARKS OF FORCIBLE USE ON THE COUPLING SHAFT AS WELL AS IN THE RECEIVING BORE FOR THE ATTACHMENTS. THE COUPLING SLEEVE IS SEIZED ON THE SHAFT. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCT. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED BY EXTENSIVE USE.

    Description of Event or Problem · 1

    DURING A HIP SURGERY ON (B)(6) 2013, AS THE SURGEON WAS PERCUTANEOUSLY PINNING THE HIP WITH 7.3MM CANNULATED SCREWS, THE LARGE QUICK COUPLING INSTRUMENT WOULD NOT OPEN. THE SURGEON WAS ABLE TO USE A REGULAR CHUCK AND THE SURGERY PROCEEDED NORMALLY WITH NO HARM TO THE PATIENT REPORTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204283 LARGE QUICK COUPLING FZX SYNTHES GMBH 1316186

    Patients

    Seq Age Sex Outcome Treatment
    1