BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCH BIOCOMP SWIV SP, SELF-PUN 4.75X24.5MM

    MDR report key: 3101364 · Received May 9, 2013

    Report

    Report Number
    1220246-2013-00077
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    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 CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. EVALUATION OF THE RETURNED DEVICE CONFIRMS THAT THE IMPLANT WAS BROKEN AS ONLY THE PROXIMAL SECTION WAS RETURNED FOR EVALUATION. THE DRIVER'S METAL SHAFT WAS FOUND TO BE BENT AND THE OUTER ABS SLEEVE WAS FLARED OPEN AT THE DISTAL END AS A RESULT OF IT THREADING OVER THE IMPLANTS PROXIMAL END. COMPLAINANT'S EVENT TYPICALLY CAUSED BY 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 INSERTION, THE ANCHOR BROKE INTO 2 PIECES, ONE PART WAS REMOVED AND RETURNED, ONE REMAINED INSIDE BONE TUNNEL. NO FURTHER INFORMATION GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203802 SUTURE ANCH BIOCOMP SWIV SP, SELF-PUN 4.75X24.5MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 522179

    Patients

    Seq Age Sex Outcome Treatment
    1 Other