BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 10305175 · Received July 21, 2020

    Report

    Report Number
    0001526350-2020-00625
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 26, 2020
    Report Date
    September 14, 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 · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. PRODUCT REVIEW OF THE ZIMMER SKIN GRAFT MESHER (00770100000) SERIAL NUMBER (B)(6) BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR SITE - AUSTRALIA ON 6 JULY 2020 REVEALED THAT THE GRATE WAS BENT. AFTER INVESTIGATION, THE REPORTED EVENT WAS VERIFIED; THE COMB WAS REPLACED. ADDITIONALLY, THE HANDLE PIN WAS WORN AND REQUIRED REPLACEMENT. REPAIR OF THE DEVICE WAS PERFORMED BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR SITE - AUSTRALIA ON 6 JULY 2020 WHICH INCLUDED REPLACEMENT OF THE FOLLOWING: ZSGM COMB (PN R6001810444, LN N/A). SLIDING PIN (PN R6001810569, LN N/A). ADDITIONAL REPAIR INCLUDED CLEANING, LUBRICATION, AND CALIBRATION. THE DEVICE, SERIAL NUMBER (B)(6) , WAS THEN TESTED AND FUNCTIONED PROPERLY. 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. THE EVENT IS CONFIRMED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE AN EVALUATION OF THIS DEVICE IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED. Z.S.G.M. CUTTER 2:1 RATIO CAUTION: SHARP; PART NUMBER: 00-7703-020-00; SERIAL NUMBER: (B)(4). Z.S.G.M. CUTTER 1.5:1 RATIO CAUTION: SHARP; PART NUMBER: 00-7703-015-00; SERIAL NUMBER: (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAS A BENT GRATE. THE BEGINNING OF THE PROCEDURE WAS DELAYED AN UNKNOWN AMOUNT, BUT THE PATIENT WAS NOT YET UNDER ANESTHESIA. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765181 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 61377302

    Patients

    Seq Age Sex Outcome Treatment
    1