BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM

    MDR report key: 2006314 · Received March 3, 2011

    Report

    Report Number
    1220246-2011-00030
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. ONE BIO-TENODESIS SCREW DRIVER WAS RETURNED. THE DISTAL HEXAGONAL DRIVER TIP WAS BROKEN-OFF. NO OTHER DAMAGE OR OTHER ABNORMALITIES WERE OBSERVED. THE MATERIAL TYPE AND ALL MEASURABLE CRITICAL DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION. THE COMPLAINANT'S EVENT IS MOST LIKELY CAUSED BY PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT NUMBER COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TIP OF DRIVER BROKE OFF IN THE SCREW DURING A WRIST PROCEDURE. SURGEON TRIED TO REMOVE IT BUT THE SCREW WAS FIRMLY IN THE BONE, HOLDING THE TENDON. HE DID NOT WANT TO JEOPARDIZE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 253139

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other