BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC SCREW BONE AWL, SS

    MDR report key: 1894476 · Received November 9, 2010

    Report

    Report Number
    2027467-2010-00016
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    PMA / PMN Number
    K052201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE RETURNED BONE AWL REVEALED THE INSTRUMENT WAS PROPERLY MANUFACTURED TO DESIGN SPECIFICATIONS. INSPECTION OF THE FRACTURE SITE INDICATED THE TIP SHEARED OFF IN A DIRECTION THAT IS NOT CONSISTENT WITH THE INTENDED USE OF THE INSTRUMENT. THE BONE AWL IS INTENDED TO PENETRATE CORTICAL BONE BY ROTATING THE INSTRUMENT ON ITS AXIS. THE INSTRUMENT IS NOT INTENDED TO PRY AND/OR MOTION FORCEFULLY INFERIOR/SUPERIOR AS DESCRIBED BY THE USER.

    Description of Event or Problem · 1

    DURING AN UPPER THORACIC CASE, THE TIP OF THE BONE AWL FRACTURED AND SEPARATED FROM THE INSTRUMENT. THIS OCCURRED WHILE THE SURGEON WAS MANEUVERING THE HANDLE OF THE AWL INFERIOR/SUPERIOR TO GET HIS TRAJECTORY. THE FRACTURED TIP WAS REMOVED FROM THE PATIENT WITHOUT ISSUE BY THE SURGEON USING A DRILL. THE PATIENT DID NOT RETAIN A FOREIGN BODY. ADDITIONALLY, THE REPORT STATED THE SURGEON MENTIONED THAT HE MOST LIKELY TILTED THE HANDLE TOO FORCEFULLY AND QUICKLY WHILE THE TIP WAS IN THE BONE, THUS CAUSING IT TO SNAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACIC SCREW BONE AWL, SS KWP,MNI KWP ALPHATEC SPINE INC 63914 5741803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other