BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF CONSTRAINED AWL (STAINLESS STEEL)

    MDR report key: 7039007 · Received November 16, 2017

    Report

    Report Number
    2027467-2017-00083
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 23, 2017
    Report Date
    October 24, 2017
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HWJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE RETURNED DEVICE REVEALED A FRAGMENT OF THE DISTAL TIP HAD BROKEN AND DETACHED FROM THE INSTRUMENT. THE REMAINDER OF THE POINTED EDGES ARE SLIGHTLY BENT/DEFORMED AND NO LONGER SHARP. THE MANIPULATION APPEARS TO BE CONSISTENT WITH THAT OF POSSIBLY IMPACTING/STRIKING WITH EXCESSIVE FORCE AT THE PROXIMAL END OF THE INSTRUMENT. THE SELF CONSTRAINED AWL IS DESIGNED TO CREATE A PILOT HOLE THROUGH CORTICAL BONE BY PUSHING DOWN ON THE HANDLE OF THE INSTRUMENT.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT THE TIP OF THE AWL IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815607 SELF CONSTRAINED AWL (STAINLESS STEEL) HWJ HWJ ALPHATEC SPINE INC 61730 5873701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other