BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMP SLEEVE GRIP CRIMPER

    MDR report key: 7778599 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-04855
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    June 13, 2018
    Report Date
    May 13, 2019
    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
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORT SOURCE : FOREIGN: EUROPE: FRANCE. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE JAW OF THE INSTRUMENT IS FRACTURED. THE FRACTURED SURFACE SHOWS ARTIFACTS THAT SUGGEST A BENDING OVERLOAD FRACTURE. MATERIAL ANALYSIS AND HARDNESS CHECK DETERMINED THE PRODUCT IS CONFORMING TO SPECIFICATIONS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 · 0

    IT IS REPORTED THAT THE PRODUCT FRACTURED DURING THE SURGERY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PRODUCT FRACTURED DURING THE SURGERY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618347 BMP SLEEVE GRIP CRIMPER TRAUMA, INSTRUMENT HXQ ZIMMER BIOMET, INC. N/A 637670

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR