BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 8625156 · Received May 20, 2019

    Report

    Report Number
    0001526350-2019-00380
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 1, 2019
    Report Date
    May 20, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD FOR ZIMMER AIR DERMATOME SERIAL NUMBER (B)(4) WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE RECORD REVIEWS FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. USING THE MACHINE-REPAIR REPORTS AND THE REPAIR SITES FOLDERS ON LIVELINK AS WELL AS SAP TO QUERY FOR ALL REPAIRS ON SERIAL NUMBER (B)(4) PRIOR TO (B)(6) 2019, THE DEVICE WAS NOTED TO HAVE NOT BEEN PREVIOUSLY REPAIRED. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO PERFORMED THE EVALUATION AND REPAIR. ON (B)(6) 2019, IT WAS REPORTED FROM ZIMMER BIOMET (B)(4). THAT A DERMATOME WOULD NOT WORK WITH AN AIR HOSE; THERE WAS NO LEAKING. THE CUSTOMER RETURNED A ZIMMER AIR DERMATOME SERIAL NUMBER 113411 FOR EVALUATION. EVALUATION OF THE DEVICE ON (B)(6) 2019 NOTED THAT THE MOTOR WAS RUNNING ERRATICALLY ON THE DEVICE AND THAT THE DEVICE WAS OUT OF CALIBRATION AT THE ZERO SETTING ONLY. UPON FURTHER EVALUATION, IT WAS FOUND THAT THE PIN ON THE NECK THAT HOLDS THE RECIPROCATING ARM WAS BENT, CAUSING THE RECIPROCATING ARM TO BIND UP. REPAIR OF THE DERMATOME OCCURRED THE SAME DAY AND INVOLVED REPLACING THE MOTOR, MULTIPLE BEARINGS, AND THE RECIPROCATING ARM AS WELL AS STRAIGHTENING OUT THE PIN ON THE NECK SO THE RECIPROCATING ARM WOULD MOVE MORE SMOOTHLY. THE TECHNICIAN THEN TESTED THE DEVICE AND VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED, THEN RETURNED THE DEVICE TO THE CUSTOMER WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. REFERENCE NUMBER (B)(4) ON (B)(6) 2019. DURING EVALUATION, THE SERVICE TECHNICIAN FOUND THAT THE PIN THAT CONNECTS THE NECKPIECE TO THE RECIPROCATING ARM WAS DAMAGED. THIS WOULD PREVENT THE RECIPROCATING ARM FROM BEING HELD IN PLACE AND THEREFORE CAUSE THE ECCENTRIC SHAFT TO NOT CONSISTENTLY COME IN CONTACT WITH THE TWO POSTS ON THE RECIPROCATING ARM. WHEN THIS WOULD HAPPEN, THE RECIPROCATING ARM WOULD THEN BE ABLE TO FLUCTUATE HOW FAST IT VIBRATE THE BLADE AT RANDOM INTERVALS AND THEREFORE LEAD TO THE DERMATOME NOT CUTTING A GRAFT PROPERLY. WHILE THIS WAS FOUND, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED AS TO WHAT CAUSED THE PIN ON THE NECKPIECE TO BECOME DAMAGED SUCH THAT THE RECIPROCATING ARM CANNOT SIT ON IT PROPERLY. THEREFORE, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DIDN'T WORK WITH AIR HOSE. THERE WAS NOTHING LEAKING. THE EVENT OCCURRED DURING DAILY KIT INSPECTION. DURING EVALUATION, THE SERVICE TECHNICIAN FOUND THAT THE PIN THAT CONNECTS THE NECKPIECE TO THE RECIPROCATING ARM WAS DAMAGED. THIS WOULD PREVENT THE RECIPROCATING ARM FROM BEING HELD IN PLACE AND THEREFORE CAUSE THE ECCENTRIC SHAFT TO NOT CONSISTENTLY COME IN CONTACT WITH THE TWO POSTS ON THE RECIPROCATING ARM. WHEN THIS WOULD HAPPEN, THE RECIPROCATING ARM WOULD THEN BE ABLE TO FLUCTUATE HOW FAST IT VIBRATE THE BLADE AT RANDOM INTERVALS AND THEREFORE LEAD TO THE DERMATOME NOT CUTTING A GRAFT PROPERLY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417590 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 63817611

    Patients

    Seq Age Sex Outcome Treatment
    1