BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.25MM VS PLATE 4-HOLE LEFT

    MDR report key: 6432649 · Received March 24, 2017

    Report

    Report Number
    0001825034-2017-02049
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    February 15, 2017
    Report Date
    December 29, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    NDF
    PMA / PMN Number
    PK010551
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. CORRECTED. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PLATE HAS SCRATCHES & DEFORMATIONS. THE FRACTURE OCCURRED NEAR THE BASE OF THE SIDE HOLE EYELET. THE PLATE¿S FRACTURE SURFACES ARE SEEN WITH POSSIBLE MULTIPLE 2-WAY BENDING OVERLOAD FRACTURES. THE FRACTURED PIECE¿S FRACTURE SURFACES SHOW SIMILAR ARTIFACTS, SUGGESTING PROBABLE 2-WAY BENDING OVERLOAD FRACTURES & LIKELY MULTIPLE ORIGINS. AN XRF SCAN CONFIRMED THE PLATE¿S COMPOSITION AS CONFORMING TO SPECIFICATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORETED WHILE THE SURGEON WAS BENDING THE PLATE DURING A PROCEDURE, IT FRACTURED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATIVE PLATE. NO FRACTURED PIECES FELL INTO THE PATIENT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216538 6.25MM VS PLATE 4-HOLE LEFT PLATE, FIXATION NDF BIOMET TRAUMA NI 949097

    Patients

    Seq Age Sex Outcome Treatment
    1