BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENODESIS SCREW, BIOCOMPOSITE

    MDR report key: 2954898 · Received February 11, 2013

    Report

    Report Number
    1220246-2013-00013
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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. DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. THE EVALUATION REVEALED THAT ONE OF THE RETURNED DRIVER'S DISTAL HEX DRIVE IS BROKEN-OFF AT ITS BASE AND THE FRACTURE FACE IS AT AN ANGLE TO THE DISTAL FACE OF THE DRIVER. THE OTHER RETURNED DRIVER DISPLAYS NO DAMAGE OR ANY OTHER ABNORMALITIES. THE COMPLAINANT'S EVENT WAS MOST LIKELY CAUSED BY PRYING /LEVERAGING THE DRIVER WHILE THE IMPLANT WAS STILL LOADED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTER TIP BROKE OFF IN THE IMPLANT AND REMAINS IN THE PATIENT. RIGHT THUMB ULNAR COLLATERAL LIGAMENT REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59350 TENODESIS SCREW, BIOCOMPOSITE SCREW, FIXATION, BONE HWC ARTHREX, INC. 513163

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other