BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16530004 · Received March 13, 2023

    Report

    Report Number
    0001526350-2023-00260
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Report Date
    June 27, 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
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D1, D4, G1, G3, G6, H2, H3, H4, H6 AND H10 REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE CUTTER FAILED THE TEST CUT WITH AN INCOMPLETE CUT. THE GEARS AND COLLARS WERE REPLACED; HOWEVER, THE CUTTER CANNOT BE FULLY REPAIRED WITHOUT REPLACEMENT. THE CUTTER WAS RETURNED TO THE CUSTOMER. 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. ADDITIONAL REPORTS: 0001526350-2023-00258-1. 0001526350-2023-00259-1. 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 IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED AS AN INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING 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

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FAILED ITS TEST CUT DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576650 Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 64930188

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose