BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLTHREAD PEEK ANCHOR

    MDR report key: 1213325 · Received October 29, 2008

    Report

    Report Number
    1825034-2008-00282
    Event Type
    Injury
    Date Received
    October 29, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWC
    PMA / PMN Number
    K060693
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN OPEN ROTATOR CUFF REPAIR IN 2008. DURING PROCEDURE, SUTURE ANCHORS WERE INSERTED, AND WHEN SURGEON ATTEMPTED TO REMOVE THE INSERTER SHAFT FROM THE ANCHOR, THE IMPLANT WOULD NOT DISLODGE; THE ANCHOR PULLED OUT, LEAVING A VOID. A SECOND ANCHOR WAS INSERTED A FEW CENTIMETERS AWAY, WITH THE SAME RESULTS. A 20-MINUTE DELAY IN THE PROCEDURE WAS ENCOUNTERED, AND APPROXIMATELY 10MM OF BONE WAS REMOVED WHEN THE ANCHOR WAS PULLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLTHREAD PEEK ANCHOR SCREW, FIXATION HWC BIOMET SPORTS MEDICINE N/A 306850

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability