BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMP SLEEVE GRIP CRIMPER

    MDR report key: 7262818 · Received February 12, 2018

    Report

    Report Number
    0001825034-2018-00755
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Report Date
    July 5, 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
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 498003, BMP SLEEVE GRIP CRIMPER, MMX1772, THE 498003, BMP SLEEVE GRIP CRIMPER, MMX1915. (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00754, 0001825034-2018-00753.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE COMPLAINT SAMPLES WERE EVALUATED AND THE REPORTED EVENT WAS CONFIRMED THROUGH PHYSICAL EVALUATION. THE RETURNED DEVICES UNDERWENT FRACTURE ANALYSIS AND HARDNESS TESTING. ALL DEVICES WERE IDENTIFIED TO BE FRACTURED NEAR THE BASE, HOWEVER LOT MMX1877 (FINISHED GOODS ITEM (B)(4), LOT 336650) WAS ALSO IDENTIFIED TO BE MISSING A HINGE PIN. ALL VISIBLE FRACTURE ARTIFACTS FOR THE THREE (3) DEVICES SUGGEST A BENDING OVERLOAD FAILURE, HOWEVER, THE DEVICES WERE IN CONFORMANCE WITH SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. BASED ON AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107984 BMP SLEEVE GRIP CRIMPER CRIMPER, PIN HXQ ZIMMER BIOMET, INC. N/A 336650

    Patients

    Seq Age Sex Outcome Treatment
    1