BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROFRACTURE AWL, 90 DEGREES

    MDR report key: 1662782 · Received April 14, 2010

    Report

    Report Number
    1017294-2010-00055
    Event Type
    Injury
    Date Received
    April 14, 2010
    Report Date
    April 9, 2010
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED LINVATEC HAS REQUESTED ADDITIONAL INFO REGARDING THIS EVENT. TO DATE, THIS DEVICE HAS NOT BEEN RETURNED FOR EVAL. A FOLLOW-UP REPORT WILL BE SENT UPON RECEIPT OF THIS DEVICE AND COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING REPAIR TO A LEFT ELBOW LIGAMENT, THE TIP OF THIS AWL BROKE IN THE SURGICAL SITE. THE ORIGINAL SURGERY WAS COMPLETED USING ANOTHER AWL. AN X-RAY CONFIRMED THE DETACHED TIP REMAINED IN THE SURGICAL SITE. THE SURGEON PERFORMED ANOTHER SURGERY TO REMOVE THE DETACHED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFRACTURE AWL, 90 DEGREES ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HWJ CONMED LINVATEC 320487

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S