BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 10208564 · Received June 29, 2020

    Report

    Report Number
    0001526350-2020-00559
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    April 27, 2020
    Report Date
    September 9, 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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). D4: UDI# - (B)(4). PRODUCT REVIEW OF THE ZIMMER SKIN GRAFT MESHER (00770100000) SERIAL NUMBER(B)(6) BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR SITE ¿ AUSTRALIA. ON (B)(6) 2020 REVEALED THAT THE RATCHET HANDLE WOULD NOT EASILY TURN. AFTER INVESTIGATION, THE REPORTED ISSUE WAS CONFIRMED; MISSING HANDLE GRUB SCREW. THE SCREW WAS REPLACED. REPAIR OF THE DEVICE WAS PERFORMED BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR SITE ¿ AUSTRALIA ON (B)(6) 2020 WHICH INCLUDED REPLACEMENT OF THE FOLLOWING: IMP RATCHET SET SCREW (PN R6001610570, LN N/A) ADDITIONAL REPAIR INCLUDED LUBRICATION. THE DEVICE, SERIAL NUMBER (B)(6) , WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MISSING GRUB SCREW WITHIN THE RATCHET HANDLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE EVENT IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED. THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, B4, B5, G4, G7, H2, H10.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE RATCHET HANDLE DID NOT TURN FROM 10 O'CLOCK TO 2 O'CLOCK. THE SURGEON HAD TO POSITION MESHER TO THE END OF TROLLERY AND TURN HANDLE A FULL ROTATION TO PUSH THE CARRIER THROUGH THE MESHER. THERE WAS A DELAY OF 1-15 MINUTES. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATCHET HANDLE DID NOT TURN FROM 10 O'CLOCK TO 2 O'CLOCK. THE SURGEON HAD TO POSITION MESHER TO THE END OF TROLLERY AND TURN HANDLE A FULL ROTATION TO PUSH THE CARRIER THROUGH THE MESHER. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669543 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 63704655

    Patients

    Seq Age Sex Outcome Treatment
    1