BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDPASS DISPOSABLE SUTURE LARIAT W/ NITINOL WIRE 45 DEGREE UP

    MDR report key: 1733472 · Received June 23, 2010

    Report

    Report Number
    1825034-2010-00227
    Event Type
    Malfunction
    Date Received
    June 23, 2010
    Date of Event
    April 9, 2010
    Report Date
    June 17, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1825034-2010-004R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER - ALL THREE DEVICES ATTEMPTED FOR USE WERE FROM THE SAME LOT NUMBER; 863950

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A SUTURE LARIAT ON (B) (6) 2010. DURING THE PROCEDURE, THREE LARIATS WERE ATTEMPTED FOR USE BUT FAILED TO DEPLOY THE NITINOL TO RETRIEVE THE SUTURE PRIOR TO BEING PLACED IN THE CANNULA AND USED IN THE PATIENT. THERE WAS NOT PATIENT INJURY OR SIGNIFICANT DELAY TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDPASS DISPOSABLE SUTURE LARIAT W/ NITINOL WIRE 45 DEGREE UP MANUAL, SURGICAL INSTRUMENT MDM BIOMET SPORTS MEDICINE N/A 863950

    Patients

    Seq Age Sex Outcome Treatment
    1