BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPASS PLASTIC NITINOL DISP X1

    MDR report key: 2586114 · Received May 24, 2012

    Report

    Report Number
    0001825034-2012-00654
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    April 23, 2012
    Report Date
    April 24, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF RETURNED SUTURE PASSER FOUND THAT THE TIP OF THE TOP JAW ON THE DEVICE WAS WORN. THIS REDUCES THE LENGTH OF THE TIP AND ALLOWS THE NITINOL TO NOT FOLLOW THE TIP. THE NITINOL WOULD GO IN FRONT OF THE TIP OF THE INSERTER, AND COULD FRACTURE. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00654 / 00655).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2012. DURING THE PROCEDURE, THE NITINOL WIRE FRACTURED WHILE PASSING THROUGH TISSUE. THE WIRE WAS RETRIEVED FROM THE SURGICAL SITE, AND THE PROCEDURE WAS COMPLETED, BUT ONLY AFTER A DELAY OF MORE THAN HALF AN HOUR HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPASS PLASTIC NITINOL DISP X1 PUSHER/SOCKET HXO BIOMET ORTHOPEDICS N/A 208360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R