BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREW 4.0MM, LENGTH 46MM, STAINLESS

    MDR report key: 2572850 · Received May 9, 2012

    Report

    Report Number
    8043862-2012-00001
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    April 11, 2012
    Report Date
    May 9, 2012
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HWC
    PMA / PMN Number
    K111316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE FACT THAT THE BROKEN SCREW WAS NOT RETURNED TO THE MANUFACTURER, NO SERIOUS INVESTIGATION COULD BE PERFORMED WITH REGARD TO THE TYPE OF BREAKAGE. THE DEVICE HISTORY RECORDS HAS BEEN CHECKED AND ALSO THE RAW MATERIAL DOCUMENTATION (3.1 CERTIFICATE AND METALLOGRAPHIC EXAMINATION) SHOWED NO DEVIATION FROM THE SPECIFICATION.

    Description of Event or Problem · 1

    DR (B)(6) WAS DOING A TRIPLE AND HE INSERTED TWO 4.0 L44 SCREWS WITH WASHERS AND WANTED ADDITIONAL COMPRESSION, SO HE DECIDED TO INSERT A 4.0 L46 SCREW (WITHOUT A WASHER) AND THE DRILLED AND INSERTED THE SCREW BY HAND AND THE HEAD OF THE SCREW BROKE OFF. WE LOOKED AT THE XRAY AND IT IS POSSIBLE THAT THE SCREW WAS HITTING ANOTHER SCREW FROM A UNI-CP PLATE. HE REDIRECTED THE KWIRES AND INSERTED ANOTHER 4.0 L46 SCREW WITHOUT A PROBLEM. THESE SCREWS WERE SHORT THREADED 4.0 SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREW 4.0MM, LENGTH 46MM, STAINLESS BONE SCREW HWC AAP IMPLANTATE AG 440146 QR0001

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR