BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMP SLEEVE GRIP CRIMPER

    MDR report key: 7252519 · Received February 8, 2018

    Report

    Report Number
    0001825034-2018-00403
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    November 3, 2017
    Report Date
    June 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HXQ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED THROUGH PHYSICAL EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT TO BE FRACTURED AT THE TIP, HOWEVER, FURTHER EXAMINATION OF THE FRACTURE WAS UNABLE TO BE PERFORMED AS THE DEVICE APPEARS TO HAVE BEEN WELDED BACK TOGETHER. THE DEVICE WAS ADDITIONALLY SUBJECTED TO ENERGY-DISPERSIVE X-RAY SPECTROSCOPY AND CONFIRMED TO BE IN CONFORMANCE WITH PRODUCT SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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 WAS REPORTED THAT DURING USE, THE TIP OF THE INSTRUMENT BROKE; HOWEVER, THE SURGERY TOOK PLACE NORMALLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97231 BMP SLEEVE GRIP CRIMPER CRIMPER, PIN HXQ ZIMMER BIOMET, INC. N/A 082320

    Patients

    Seq Age Sex Outcome Treatment
    1