BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )

    MDR report key: 17624004 · Received August 25, 2023

    Report

    Report Number
    0001526350-2023-00978
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    March 3, 2023
    Report Date
    August 25, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    N/A
    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 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: 0001526350-2023-00309-1. THE INVESTIGATION IS COMPLETE. THIS IS AN INITIAL FINAL REPORT SUBMISSION. REVIEW OF THE MOST RECENT REPAIR RECORD IDENTIFIED THE FOLLOWING RELATED FINDING: TECH FOUND THE CUTTER DID NOT PASS THE SAMPLE MESH TEST. THE CUSTOMER WAS NOTIFIED OF THE FAILURE AS REPAIRS ARE NOT PERFORMED FOR ZGSM ACCESSORIES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE UNIT IS NOT RATCHETING. NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER DID NOT PASS THE SAMPLE MESH TEST. NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077224 Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 33327000

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose CUTTER 3:1 RATIOPN 00770303000LN UNKNOWN