BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMP SLEEVE GRIP CRIMPER

    MDR report key: 7252512 · Received February 8, 2018

    Report

    Report Number
    0001825034-2018-00402
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    December 1, 2017
    Report Date
    June 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HXQ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL ANALYSIS CONFORMS THE CRIMPER JAW FRACTURED NEAR THE BASE. MICROSCOPIC ANALYSIS REVEALED FRACTURE ARTIFACTS SUGGESTIVE OF A BENDING OVERLOAD FAILURE. MATERIAL ANALYSIS SHOWED THE DEVICE'S MATERIAL COMPOSITION TO BE IN CONFORMANCE WITH SPECIFICATIONS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    (B)(4) (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 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
    97224 BMP SLEEVE GRIP CRIMPER CRIMPER, PIN HXQ ZIMMER BIOMET, INC. N/A 336650

    Patients

    Seq Age Sex Outcome Treatment
    1