BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-CORKSCREW SUTURE ANCHOR, 6.5 MM

    MDR report key: 2132252 · Received June 17, 2011

    Report

    Report Number
    1220246-2011-00096
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    November 10, 2006
    Report Date
    May 31, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K003227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 REQUESTED FOR EVALUATION, BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE IMPROPER BONE PREPARATION FOR THE HARDNESS OF BONE ENCOUNTERED, NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL, PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED, AND/OR OVER-INSERTION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    IMPLANT BROKE ON INSERTION DURING A " STUMP REVISION,"TIP OF SCREW HAS REMAINED IN PATIENTS BONE. FOUR SCREWS WERE USED, 3 BROKE, 2 WERE COMPLETELY REMOVED .THE CASE WAS COMPLETED USING A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CORKSCREW SUTURE ANCHOR, 6.5 MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 47307

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other