BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9-10MM SHORT EZLOC FEM FIXATN

    MDR report key: 3841337 · Received May 30, 2014

    Report

    Report Number
    0001825034-2014-05032
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK041261
    Removal / Correction Number
    N/A
    Adverse Event
    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND EVIDENCE OF PRODUCT NON-CONFORMANCE. COMPONENT WAS MANUFACTURED PRIOR TO CURRENT SPECIFICATIONS. WORK INSTRUCTIONS DETAILING THE ASSEMBLY PROCESS AND FIXTURES FACILITATING THE ASSEMBLY HAVE BEEN INITIATED TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ACL REPAIR PROCEDURE UTILIZING A FIXATION DEVICE ON (B)(6) 2014. DURING THE PROCEDURE, THE SUTURES ON THE DEVICE APPEARED TO BE LOOSE AND IT COULD NOT BE ADVANCED THROUGH THE TIBIAL TUNNEL. ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319428 9-10MM SHORT EZLOC FEM FIXATN FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 857330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention