BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 10465314 · Received August 28, 2020

    Report

    Report Number
    0001526350-2020-00727
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    March 18, 2020
    Report Date
    August 28, 2020
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). PRODUCT REVIEW OF THE ZIMMER SKIN GRAFT MESHER (00770100000) SERIAL NUMBER (B)(4) BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR SITE ¿ (B)(6) ON 14 APRIL 2020 REVEALED THAT THE PINS WERE TOO TIGHT; DIFFICULT TO PULL OUT AND PUSH IN. THE DEVICE WOULD NOT TAKE UP CARRIER AND SKIN WILL NOT FEED AT ALL. AFTER INVESTIGATION, IT WAS DETERMINED THAT THE LOCKING PINS CLOSE/OPEN CORRECTLY, BUT THE COMB WAS BENT AND NOT CUTTING CORRECTLY (FAILED MESH TEST). THE COMB WAS REPLACED AND THE DEVICE WAS RECALIBRATED. REPAIR OF THE DEVICE WAS PERFORMED BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR SITE ¿ (B)(6) ON 14 APRIL 2020 WHICH INCLUDED REPLACEMENT OF THE FOLLOWING: ZSGM COMB (PN R6001810444, LN N/A) ADDITIONAL REPAIR INCLUDED RECALIBRATION AND TESTING. THE DEVICE, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE EVENT IS CONFIRMED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PINS WERE TOO TIGHT, VERY DIFFICULT TO PULL OUT AND PUSH IN. IT WAS NOT TAKING UP CARRIER AND SKIN WAS NOT FEEDING AT ALL. EVENT OCCURRED BEFORE SURGERY. DELAY IN SURGERY WAS BETWEEN 1-15 MINUTES. THERE WAS NO HARM OR IMPACT TO GRAFT. THERE WAS NO ADVERSE EVENT REPORTED AS A RESULT OF THIS MALFUNCTION. INVESTIGATION FOUND A BENT COMB AND THE DEVICE WAS NOT CUTTING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928959 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 62976425

    Patients

    Seq Age Sex Outcome Treatment
    1