BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3750983 · Received March 10, 2014

    Report

    Report Number
    1526350-2014-00179
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 13, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 HE DEVICE WAS MANUFACTURED ON 12/13/1993 AND WAS LEAST REPAIRED DON 05/23/2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED BENT TINES ON THE RIGHT SIDE OF THE COMB, MALFUNCTIONING LATCHING PINS, DAMAGE TO THE ROLLER AND ROLLER GEAR AND DISCOLORATION TOT HE SIDE PLATES, HINGE TOPS AND CARRIER CHECK COULD NOT BE PERFORMED DUE TO THE LATCHING PINS NOT LOCKING AND THE DAMAGED COMB. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE COMB, ROLLER AND ROLLER GEAR HINGE TOPS, SIDE PLATES, SHOULDER BOLTS, CARRIER GUIDE AND WASHERS. THE CUSTOMER DID NOT RETURN A RATCHET OR CUTTERS FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE WAS IMPROPER HANDLING BY THE USER LIKELY CAUSED THE DAMAGE TO THE COMB, LATCHING PINS, ROLLER, AND ROLLER GEAR. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS BENT. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143357 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1