BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBULA COMP LOCK PLATE 10H STE

    MDR report key: 5900792 · Received August 24, 2016

    Report

    Report Number
    0001825034-2016-03215
    Event Type
    Injury
    Date Received
    August 24, 2016
    Date of Event
    March 9, 2016
    Report Date
    July 25, 2016
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K111663. (B)(4). EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE AND CONFIRMED REPORTED CONDITION. INFRARED ANALYSIS OF BLACK DEBRIS DETERMINED THE MATERIAL WAS PARTICLES OF A PROTEIN HELD IN PLACE BY VEGETABLE OIL. THE SOURCE OF THE BLACK FOREIGN SUBSTANCE IS UNKNOWN; THEREFORE, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING AN OPEN REDUCTION AND INTERNAL FIXATION FOR THE DISTAL FIBULA, BLACK WEAR DEBRIS FROM THE GUIDES WAS FOUND DURING INSERTION OF THE K-WIRE AND DRILLING A LOCKING HOLE. THE DEBRIS WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT THE GUIDES WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552222 FIBULA COMP LOCK PLATE 10H STE PLATE, FIXATION HRS BIOMET TRAUMA N/A 588300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention