BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADJ DISTAL CUT GUIDE

    MDR report key: 3825206 · Received May 21, 2014

    Report

    Report Number
    0001825034-2014-04538
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 21, 2014
    Report Date
    June 16, 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
    FL, 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

    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 CARE AND HANDLING OF INSTRUMENTS, NUMBER 1 STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING." EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO THE INSTRUMENT BEING USED BEYOND ITS USEFUL LIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, IT WAS NOTED A SCREW LOOSENED. ANOTHER SCREW WAS UTILIZED TO COMPLETE THE PROCEDURE. A 30 MINUTE DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302485 ADJ DISTAL CUT GUIDE GUIDE, SURGICAL FZX BIOMET ORTHOPEDICS N/A ZB090410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention