BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM)

    MDR report key: 17807491 · Received September 25, 2023

    Report

    Report Number
    0001526350-2023-01198
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 21, 2023
    Report Date
    January 19, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024378780
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ANGLE MEASUREMENT OF BOTH RETURNED PRODUCTS IDENTIFIED THE ANGLE OF THE CARRIERS WAS MEASURED ON OPTICAL COMPARATOR ID# 5042. ANGLE READING WAS 19 DEGREES 35 MINUTES, WHICH IS NOT IN SPECIFICATION FOR A 3:1 CARRIER BUT IS IN SPEC FOR A 1.5:1 CARRIER. 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 REPORT: 0001526350-2023-01199-1.

    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. G2: FOREIGN: JAPAN.

    Description of Event or Problem · 0

    THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE CARRYING SKIN GRAFT'S RATE OF MAGNIFICATION OF THIS COMPLAINT PRODUCT WAS DIFFERENT FROM THE SPECIFICATION. THE SURGEON SAID THE CARRYING SKIN GRAFT WAS MAGNIFICATED 1.5 TO 1, ALTHOUGH THE SPECIFICATION RATE OF MAGNIFICATION OF THIS COMPLAINT PRODUCT IS 3 TO 1. THERE WAS NO PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION, OR AN ADDITIONAL SURGERY REPORTED. THE TAKEN GRAFT WAS NOT DAMAGED. THERE WAS NO SURGICAL DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561855 3 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 65390419 00889024378780

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose