BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK

    MDR report key: 2831034 · Received November 14, 2012

    Report

    Report Number
    1220246-2012-00226
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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. TYPICALLY THIS TYPE OF EVENT IS CAUSED BY PREPARING A PILOT HOLE THAT IS TOO SMALL, INSERTING THE IMPLANT AT AN ANGLE THAT IS NOT CO-AXIAL TO THE PILOT HOLE, AND IMPACTING THE DRIVER BEFORE THE LASER LINE IS FLUSH WITH THE SURFACE OF THE PILOT HOLE. 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. DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BROKE AT THE FOURTH THREAD DURING MALLETING. THE SITE WAS PRE-DRILLED. THE FRAGMENT IN THE PATIENT WAS NOT RETRIEVED AND NOTHING WAS SECURED ON TOP OF IT. A NEW LOT WAS USED AFTER THE TWO PRIOR HAD BROKEN FOR A TOTAL OF THREE ANCHORS. THE FOURTH IMPLANTATION WAS SUCCESSFUL. LABRAL REPAIR,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 569875

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other (B)(4), LOT 569885