BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 25081999 · Received May 5, 2026

    Report

    Report Number
    0001526350-2026-00540
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 5, 2026
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). D10: MEDICAL PRODUCT - RATCHET HANDLE #00770102200, LOT: UNK, SERIAL: UNK AUTOCLAVE CASE #00770100300, LOT: UNK, SERIAL: UNK Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) #00770301500, UNK, SERIAL: UNK. Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP ) #00770302000, UNK, SERIAL: UNK. Z.S.G.M. CUTTER 3:1 RATIO ( CAUTION: SHARP ) #00770303000, UNK, SERIAL: UNK. Z.S.G.M. CUTTER 4:1 RATIO ( CAUTION: SHARP ) #00770304000, UNK, SERIAL: UNK. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. THE PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING BIOMEDICAL ENGINEERING TEST/CHECK THE UNIT HAD UNEVEN OPERATION AND THE GRAFT APPEARED TO SLANT TO ONE SIDE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490236 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1