BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3378522 · Received September 13, 2013

    Report

    Report Number
    1526350-2013-00509
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 16, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 01/14/1992 AND THE LAST REPAIR WAS ON (B)(4) 2012 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE VERIFIED THE COMB WAS DAMAGED. IT WAS ALSO OBSERVED THAT THE RIGHT END OF THE ROLLER WAS GNARLED AND THERE WAS DAMAGE TO THE SIDE PLATES. THE CUSTOMER DID NOT RETURN A RATCHET OR CUTTERS WITH THE DEVICE. PRIOR TO REPAIR, A TEST MESH AND CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB. THE DAMAGE TO THE COMB MOST LIKELY WAS THE CAUSE FOR THE EVENT EXPERIENCED BY THE CUSTOMER. IMPROPER HANDLING BY THE CUSTOMER MOST LIKELY CAUSED THE DAMAGE TO THE COMB, ROLLER, SIDE PLATES AND BUSHINGS. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ZIMMER SKIN GRAFT MESHER COMB WAS BENT. NO ADDITIONAL CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL CLINICAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461335 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1