BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3565832 · Received November 7, 2013

    Report

    Report Number
    1526350-2013-00648
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 8, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 03/09/1995 AND WAS LAST REPAIRED ON (B)(6) 2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT BOTH SET SCREWS WERE SLIGHTLY EXPOSED ON THE INTERIOR OF THE RATCHET GEAR. GALLING OF THE ROLLER GEAR TEETH WAS OBSERVED. DISCOLORATION AND WEAR TO THE REAR CROSS MEMBER WAS OBSERVED; HOWEVER, THE STRUCTURAL INTEGRITY OF THIS PART WAS NOT COMPROMISED. THERE ALSO WAS DAMAGE TO THE COMB, ROLLER, LEFT SIDE PLATE AND SHOULDER BOLTS. PRIOR TO REPAIR, A TEST MESH PASSED, BUT THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATION ON THE LEFT SIDE. CUSTOMER DID NOT RETURN ANY CUTTERS FOR EVALUATION. NO INFORMATION IS KNOWN ON THE CUTTER(S) UTILIZED DURING THE REPORTED EVENT. IMPROPER HANDLING BY THE USER MOST LIKELY CAUSED THE DAMAGE TO THE ROLLER GEAR, COMB AND LACK OF CALIBRATION, WHICH LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. ADDITIONALLY, IMPROPER HANDLING MOST LIKELY CAUSED THE DAMAGE TO THE ROLLER, LEFT SIDE PLATE AND SHOULDER BOLTS. 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 NOT MESHING SKIN. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL CLINICAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577062 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1