BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT EXACT BROACH HANDLE

    MDR report key: 8146836 · Received December 10, 2018

    Report

    Report Number
    0001825034-2018-10885
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 15, 2018
    Report Date
    February 7, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THE STRIKE PLATE TO BE FRACTURED FROM THE HANDLE BODY. IMPACT MARKS WERE OBSERVED ON ALL SIDES OF THE HANDLE BODY AND STRIKE PLATE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE FRACTURED DEVICE IS NOTED IN SEM#1901-017 AND ZRM_WA_0488_18 AS A TENSILE OVERLOAD FAILURE. THE DEVICE WAS DETERMINED TO BE CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN SOURCE: (B)(6). 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 REPORTED THAT PRIOR TO SURGERY, IT WAS NOTICED THAT THE INSTRUMENT HANDLE WAS FRACTURED. NO ADVERSE EVENT NOTED TO PATIENT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986192 STRAIGHT EXACT BROACH HANDLE INSTRUMENT, HIP LXH ZIMMER BIOMET, INC. N/A ZB161211

    Patients

    Seq Age Sex Outcome Treatment
    1