BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 17797991 · Received September 22, 2023

    Report

    Report Number
    0001526350-2023-01179
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 30, 2023
    Report Date
    February 29, 2024
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001526350-2023-01180-1 THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D4, D9, G3, G6, H2, H3, H4, H6, H10. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE RATCHET PASSED INSPECTION; HOWEVER, THE COMB WAS DAMAGED AND THE DEVICE WAS OUT OF CALIBRATION. THE COMB WAS REPLACED AND THE DEVICE WAS RECALIBRATED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO DESIGN ISSUE. THE EVENT CANNOT BE 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.

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2 FOREIGN: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001526350-2023-01180 THE CUSTOMER HAS INDICATED THAT THE DEVICE IS IN PROCESS OF BEING RETURNED TO THE MANUFACTURER FOR EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OUTSIDE OF SURGERY 2 MESHERS FAILED TO RATCHET. THE HANDLE HAD TO BE ROTATED IN A FULL 360 DEGREE CIRCLE TO DRAW THE MESH GRAFT CARRIER THROUGH THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT WITH NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526739 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 64371099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose