BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPASS DISPOSABLE NITINOL SINGLE PACK

    MDR report key: 1644160 · Received March 29, 2010

    Report

    Report Number
    1825034-2010-00101
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 4, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HXO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS UNDAMAGED. FUNCTIONAL EVALUATION OF THE DEVICE IN CONJUNCTION WITH THE SUTURE PASSER INSTRUMENT, IT WAS ATTEMPTED FOR USE WITH FOUND THAT IT COULD NOT BE PROPERLY INSERTED INTO THE SUTURE PASSER INSTRUMENT. THE SUTURE PASSER CANNULATION APPEARED TO BE BLOCKED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A SUTURE PASSER ON (B)(6) 2010. DURING THE PROCEDURE, THE NITINOL WIRE FRACTURED INSIDE THE PASSER AND WOULD NOT PUSH THE SUTURE. THERE WAS NO DELAY TO THE PROCEDURE OR INJURY TO THE PATIENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPASS DISPOSABLE NITINOL SINGLE PACK PUSHER HXO BIOMET SPORTS MEDICINE N/A 335180

    Patients

    Seq Age Sex Outcome Treatment
    1