BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK

    MDR report key: 3101347 · Received May 9, 2013

    Report

    Report Number
    1220246-2013-00073
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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 NOT CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE COMPLAINT DEVICE WAS RECEIVED CONSISTING OF EYELET AND DRIVER ONLY. THE PUSHLOCK ANCHOR WAS NOT RETURNED FOR EVALUATION. MATING DRIVER FEATURES FOUND TO BE WITHIN SPECIFICATION. AS THE ANCHOR COMPONENT WAS NOT RETURNED FOR EVALUATION THE COMPLAINANT'S EVENT CANNOT BE VERIFIED. THE MOST LIKELY CAUSE(S) OF THIS EVENT INCLUDE NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL OR PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS 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 DURING A BANKART REPAIR, THE IMPLANT BROKE AT THE LEVEL OF THE LAST TURN. THE SURGICAL TECHNIQUE WAS FOLLOWED CAREFULLY. THE PROCEDURE WAS COMPLETED EVEN THOUGH PART OF THE FRAGMENT COULD NOT BE REMOVED BUT IS SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202900 SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 464097

    Patients

    Seq Age Sex Outcome Treatment
    1 Other