BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 4745002 · Received April 30, 2015

    Report

    Report Number
    1526350-2015-00084
    Event Type
    Injury
    Date Received
    April 30, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 2, 2015
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 31, 2012, US AND CANADIAN CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR DEVICE INFORMING THEM OF IMPROPERLY MAINTAINING INSTRUMENTS THAT MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. THE DEVICE WAS MANUFACTURED ON 11/20/1995 AND WAS PREVIOUSLY REPAIRED 05/08/2013 FOR A NON-RELATED ISSUE. INVESTIGATION REVEALED THE HANDPIECE, SERIAL NUMBER (B)(4), CONTAINED COMPONENTS WITH THE LEAD SOLDER. PRIOR TO REPAIR, THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATIONS AND THE MASTER BLADE WAS FLUSH WITH THE CONTROL BAR. THE DEVICE WAS WITHIN CALIBRATION AND SIDE TO SIDE SPECIFICATIONS AT ALL TESTED THICKNESS SETTINGS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE COMPONENTS CONTAINING THE LEAD SOLDER, THE HOUSING SHAFT AND THE STANDARD REPAIR PARTS. THE REPAIR TECH NOTED NO ISSUES WITH THE POWER SUPPLY, SERIAL NUMBER (B)(4). THE POWER SUPPLY MET ALL SPECIFICATIONS AND DID NOT NECESSITATE REPAIR. THE REPORTED EVENT WAS NOT CONFIRMED DURING TESTING AND THE HANDPIECE MET CALIBRATION AND MOTOR SPEED SPECIFICATIONS. THERE IS NO INFO REGARDING THE TECHNIQUE USED DURING THE EVENT, HOWEVER, IMPROPER USER TECHNIQUE CAN LEAD TO UNDESIRABLE GRAFT RESULTS. THE HANDPIECE, SERIAL NUMBER (B)(4), IS A LOANER UNIT AND WAS REPAIRED AND RETURNED TO THE LOANER POOL. THE POWER SUPPLY, SERIAL NUMBER (B)(4), DID NOT NECESSITATE REPAIR AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DERMATOME WAS NOT FUNCTIONING PROPERLY. INITIALLY, THE GENERATOR BOX SEEMED TO CAUSE THE DERMATOME TO PRODUCE A SOUND THAT WAS NOT NORMAL. THE BOX WAS SWITCHED OUT. INITIALLY, THE SKIN BEING REMOVED WITH THE DERMATOME WAS EVEN AND INTACT. MIDWAY THROUGH OBTAINING THE GRAFT, THE DERMATOME SUDDENLY "SKIPPED" AND SHREDDED THE GRAFT INTO PIECES. AFTER THE DERMATOME SKIPPED, THE BLADE WAS CHANGED AND THE REST OF THE SKIN GRAFT WAS TAKEN. THE SECOND ATTEMPT ALSO PRODUCED A THIN AND UNEVEN GRAFT. THE DERMATOME WAS A LOANER AND REMOVED FROM SVC AND GIVEN TO ENGINEERING. CLINICAL ENGINEERING ALSO QUARANTINED THE GENERATOR BOX. PER REPORTER, THE SURGEON SAID THE UNIT DIDN'T SOUND RIGHT, CHANGED THE POWER SUPPLY, SHREDDED THE GRAFT. THEY TRIED A NEW BLADE, STILL SHREDDED THE GRAFT. BOTH GRAFTS WERE THIN AND WAVY BUT WERE USED ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284453 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) ELECTRIC DERMATOME POWER SUPPLY