BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE BONE AWL

    MDR report key: 5123270 · Received October 2, 2015

    Report

    Report Number
    3005673311-2015-00152
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Report Date
    December 10, 2015
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    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

    MANUFACTURNG SITE EVALUATION: ON-GOING.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: DEVICE WAS FOUND TO BE BROKEN IN THE AREA OF THE FLEXIBLE PORTION OF THE SHAFT. THE ISSUE HAS BEEN DETERMINED TO BE RELATED TO THE DESIGN OF THE PRODUCT. CORRECTIVE/PREVENTIVE ACTION HAS BEEN INITIATED. IT HAS BEEN DETERMINED THAT A RECALL OF THESE DEVICES IS NECESSARY AND HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). RELATED TO MEDWATCH REPORTS 2916714-2015-00107 AND 2916714-2015-00153. SJ607R = FLEXIBLE CENTER PUNCH, THIS WAS USED UNDER "NORMAL ROTATION AND PRESSURE LOAD", AND THEN BROKE AT THE THIN TRANSITIONS OF THE MOVABLE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656547 FLEXIBLE BONE AWL AWL HWJ AESCULAP IMPLANT SYSTEMS SJ607R 52024048

    Patients

    Seq Age Sex Outcome Treatment
    1 Other