BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOGGLELOC/WASHERLOC DISPOSABLE KIT

    MDR report key: 4782156 · Received May 19, 2015

    Report

    Report Number
    0001825034-2015-02088
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 21, 2015
    Report Date
    August 26, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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

    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 PRECAUTIONS, IT STATES, "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ON (B)(6) 2015. DURING THE PROCEDURE, METAL WAS STRIPPED FROM THE K-WIRE WHEN IT WAS PASSED THROUGH THE FEMORAL AIMER. THE METAL FRAGMENTS WERE REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ON (B)(6) 2015. DURING THE PROCEDURE, METAL WAS STRIPPED FROM THE OUTSIDE OF THE DRILL WHEN IT WAS PASSED THROUGH THE FEMORAL AIMER. THE METAL FRAGMENTS WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324996 TOGGLELOC/WASHERLOC DISPOSABLE KIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 343850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention