BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD POST OSTEOPHYTE CHISEL

    MDR report key: 7340793 · Received March 15, 2018

    Report

    Report Number
    0001825034-2018-01814
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 14, 2018
    Report Date
    December 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    FZO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED EVENT AS THE STRIKE PLATE HAS FRACTURED OFF OF THE HANDLE. DHR 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE - FZO. (B)(6). REPORTER HAD INDICATED THAT PRODUCT WILL BE RETURNED. 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 WAS REPORTED THAT THE STRIKE PLATE FRACTURED OFF THE DEVICE WHILE MALLETING, DURING A TOTAL KNEE ARTHROPLASTY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EFFECTS OCCURRED AS A RESULT OF THE MALFUNCTION. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186270 VANGUARD POST OSTEOPHYTE CHISEL CHISEL, SURGICAL FZO ZIMMER BIOMET, INC. N/A ZB111201

    Patients

    Seq Age Sex Outcome Treatment
    1