BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMP SLEEVE GRIP CRIMPER

    MDR report key: 6751428 · Received July 28, 2017

    Report

    Report Number
    0001825034-2017-05217
    Event Type
    Injury
    Date Received
    July 28, 2017
    Date of Event
    June 19, 2017
    Report Date
    October 2, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HXQ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT IS REPORTED THAT DURING A PROCEDURE, THE CERCLAGE CLAMP BROKE. DUE TO THE MALFUNCTION, THE CERCLAGE CABLES HAD TO BE REMOVED, AND THE SURGEON HAD TO USE A DIFFERENT, THINNER CABLE WHICH WAS NOT THE MOST APPROPRIATE FOR THIS PROCEDURE. THERE WAS A TWO (2) HOUR DELAY TO THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532163 BMP SLEEVE GRIP CRIMPER CRIMPER, PIN HXQ BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R