BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, PEEK SWI- VELOCK C, 4.75 X 19.1MM

    MDR report key: 3800607 · Received May 8, 2014

    Report

    Report Number
    1220246-2014-00069
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 11, 2014
    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 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 REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL, PRYING OR LEVERAGING OR IMPROPER BONE PREPARATION. 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. DEVICE WAS DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVING SHAFT ON SWIVELOCK STARTED TO FOLD OVER THE ANCHOR DURING INSERTION. THE ANCHOR WAS HALF INSERTED THEN THE DRIVER SHAFT FOLDED OVER AND THE SURGEON WAS FORCED TO SHAVE DOWN HALF THE ANCHOR THAT WAS SITTING PROUD IN THE CALCANEAL. HARD BONE AREA PREPARED WITH 25MM TUNNEL AND 4MM DRILL BIT. THE CASE WAS FINISHED SUCCESSFULLY AND OUTCOME WAS ACHIEVED BUT NOT ACCORDING TO THE SURGICAL TECHNIQUE. FOLLOW-UP INFORMATION: THE EYELET AND HALF THE ANCHOR BROKE OFF AND THE SURGEON USED BONE NIBBLERS TO REMOVE THE PROUD PROMINENCE OF THE ANCHOR. FRAGMENTS WERE STUCK IN BONE AND THE SURGEON WAS SATISFIED WITH FIXATION THERE ARE NO FURTHER INFORMATION REGARDING THE PATIENTS' ACTUAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279385 SUTURE ANCHOR, PEEK SWI- VELOCK C, 4.75 X 19.1MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 1138609

    Patients

    Seq Age Sex Outcome Treatment
    1 Other