BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER® S.G. CARRIER 8 IN LENGTH (FOR USE WITH ZIMMER® SKIN GRAFT MESHER ONLY)

    MDR report key: 21473029 · Received February 26, 2025

    Report

    Report Number
    0001526350-2025-00258
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    January 31, 2025
    Report Date
    August 18, 2025
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024375482
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2 FOREIGN: UNITED KINGDOM. EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN CORRECTED/UPDATED: B4, B5, D2, D4, D10, G1, G3, G6, H1, H2, H4, H6, H11. D10: CONCOMITANT THERAPY. ITEM#: 00770800010, ZIMMER® S.G. CARRIER 8 IN LENGTH, LOT#: 79406246. ITEM#: UNK, UNKNOWN SKIN GRAFT MESHER, SERIAL#: UNK, LOT#: UNK. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; FUNCTIONAL, VISUAL, AND/OR DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE CARRIER DID NOT EASILY GO THROUGH THE MESHER, CAUSING THE NORMAL SIZE AND THICKNESS SKIN GRAFT TO BECOME CAUGHT IN THE ROLLER. AN ALTERNATE DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AND AN ADDITIONAL SKIN GRAFT WAS REQUIRED FROM THE PATIENT. NO DELAY TO THE PROCEDURE WAS REPORTED. DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION. NO ADDITIONAL CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617488 ZIMMER® S.G. CARRIER 8 IN LENGTH (FOR USE WITH ZIMMER® SKIN GRAFT MESHER ONLY) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 79406246 00889024375482

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10 NARRATIVE.