BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM PEEK ALLTHREAD KNOTLESS

    MDR report key: 3250521 · Received July 26, 2013

    Report

    Report Number
    0001825034-2013-02953
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWC
    PMA / PMN Number
    PK080088
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A ROTATOR CUFF REPAIR UTILIZING A SUTURE ANCHOR ON (B)(6) 2013. DURING THE PROCEDURE, THE SUTURE ANCHOR FRACTURED IN THE PATIENT'S BONE UPON INSERTION. THE SURGEON REMOVED THE FRACTURED PIECE AND USED ANOTHER SUTURE ANCHOR TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349792 4.5MM PEEK ALLTHREAD KNOTLESS SCREW, FIXATION, BONE HWC BIOMET SPORTS MEDICINE N/A 304720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention