BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 16303508 · Received February 6, 2023

    Report

    Report Number
    0001526350-2023-00138
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Report Date
    May 1, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024375390
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. ASSOCIATED CUTTERS MEDWATCH: 0001526350-2023-00136, AND 0001526350-2023-00137.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE CALIBRATION AND TEST CUT COULD NOT BE PERFORMED DUE TO A DAMAGED COMB. THE SIDE PLATES WERE VISIBLY WORN. THE SIDE PLATES, BOTTOM ROLL, GEAR, COMB, 2 WASHERS, AND SHOULDER BOLT WERE REPLACED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-00136-1. 0001526350-2023-00137-1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE DEVICE WAS PULLING ON THE SKIN. DURING REPAIR IT WAS NOTED THAT THE COMB WAS DAMAGED. AN ADDITIONAL SURGERY WAS NOT NEEDED. THERE WAS NO HARM/INJURY TO THE PATIENT. AN UNPLANNED ADDITIONAL GRAFT WAS NOT NEEDED AND THE TAKEN GRAFT WAS NOT DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENTS ARE ASSOCIATED WITH THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114706 ZIMMER SKIN GRAFT MESHER SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. N/A 63924180 00889024375390

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown