BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER S.G. MESHER KIT

    MDR report key: 9530027 · Received December 30, 2019

    Report

    Report Number
    0001526350-2019-01200
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    December 13, 2019
    Report Date
    April 27, 2020
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THIS REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING FIELDS WERE UPDATED/ CORRECTED: B4, B5, D4, D10, G4, G7, H2, H3, H4, H6, H8, H10. -ZIMMER S.G. MESHER SERIAL NUMBER (B)(6) HAS BEEN PREVIOUSLY REPAIRED/EVALUATED ONE TIME AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS 07 NOVEMBER 2019 BY FLEXTRNOICS WHERE IT WAS REPORTED THAT THE CUTTER GETS STUCK TO THE COMB. THIS IS A RELATED ISSUE. -PRODUCT REVIEW OF THE ZIMMER S.G. MESHER SERIAL NUMBER (B)(6) BY FLEXTRNOICS ON 15 JANUARY 2020 REVEALED THAT THE UNIT WAS FULLY FUNCTIONAL. -REPAIR OF THE DEVICE WAS NOT PERFORMED BECAUSE THE DEVICE WAS FULLY FUNCTIONAL DURING THE INVESTIGATION, AND THE CUTTERS PASSED INSPECTION. -REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. -DEVICE IS USED FOR TREATMENT. -A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE DEVICE HAVING NO PROBLEM DURING THE INVESTIGATION. -NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. -THE EVENT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    EVENT OCCURRED DURING SURGERY. CUSTOMER INFORMED THAT THIS DID NOT CAUSE ANY HARM TO THE PATIENT. FOR OPERATOR THE ONLY HARM WAS THAT THEY HAD TO TAKE ANOTHER MESHER, WHICH TOOK ONLY FEW MINUTES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE CUTTER GETS STUCK TO THE COMB, PINS GET STUCK - IMPOSSIBLE TO OPEN THEM, AND THE DERMACARRIER DOES NOT SLIDE IN. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324661 ZIMMER S.G. MESHER KIT EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 63037204

    Patients

    Seq Age Sex Outcome Treatment
    1