BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL DISPOSABLE INST KIT

    MDR report key: 3840412 · Received May 30, 2014

    Report

    Report Number
    0001825034-2014-05014
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    FZX
    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

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "CORRECT HANDLING OF INSTRUMENTS IS EXTREMELY IMPORTANT. MOST INSTRUMENTS ARE NOT INTENDED TO BE MODIFIED, NOTCHED, BENT, ETC. AS NOTCHES, SCRATCHES OR OTHER DAMAGE AND/OR WEAR IN THE INSTRUMENT OCCURRING DURING SURGERY MAY AFFECT THE PERFORMANCE OF THE INSTRUMENT OR CONTRIBUTE TO BREAKAGE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THE GUIDE WIRE FRACTURED IN THE FEMORAL TUNNEL. AS A RESULT, THERE WAS A 45 MINUTE DELAY IN THE PROCEDURE. THE GUIDE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND NO PIECES WERE RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318666 ACL DISPOSABLE INST KIT GUIDE, SURGICAL FZX BIOMET ORTHOPEDICS N/A 103760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R