BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPASS SUTURE PASSER

    MDR report key: 1061308 · Received June 16, 2008

    Report

    Report Number
    2027970-2008-00012
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 23, 2008
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: REPORTED PRODUCT PROBLEM COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE SURGEON COULD NOT GET THE INSTRUMENT TO FUNCTION PROPERLY WHILE IN SURGERY. A SECOND ATTEMPT USING A DIFFERENT INSTRUMENT WITH A NEW LOT NUMBER WAS ALSO UNSUCCESSFUL. AN ALTERNATIVE METHOD HAD TO BE USED TO RETRIEVE AND TIE THE SUTURE, DELAYING THE CASE 1 HOUR. THE PATIENT SUFFERED NO ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPASS SUTURE PASSER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET SPORTS MEDICINE 902096 L675740

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other