BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR AIR DERMATOME HANDPIECE

    MDR report key: 7472188 · Received April 30, 2018

    Report

    Report Number
    0001526350-2018-00375
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 23, 2018
    Report Date
    May 30, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT IS RECORDED WITH ZIMMER BIOMET UNDER CMP-(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ON APRIL 26, 2018, IT WAS REPORTED THAT THE DEVICE WAS SENT IN FOR MAINTENANCE AS IT SEEMS TO NOT GRAFT THE SKIN AS IT SHOULD. THE DEVICE IS TAKING A THIN GRAFT EVEN IF IT HAS BEEN ADJUSTED TO TAKE A THICKER ONE. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER 112108, FOR EVALUATION. THE CUSTOMER ALSO RETURNED A HOSE, FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) AND PREVIOUS REPAIR REPORT REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR AND PREVIOUS REPAIR REPORT REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(4) ONE TIME AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS MAY 25, 2016 WHERE IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY AND THE BALL BEARINGS, O-RINGS, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARING, VESPEL SLEEVE BEARING, POPPET HOUSING, POPPET SPRING, THROTTLE HINGE, THROTTLE HINGE GASKET, SEAL SCREW, POPPET, BALL PLUNGER AND LEVER WERE REPLACED. THIS IS NOT A RELATED ISSUE. PRODUCT REVIEW OF THE AIR DERMATOME BY MEDICREA ON MAY 14, 2018 REVEALED THAT THE AIR MOTOR WAS IN GOOD CONDITION WITH A GOOD TORQUE VALUE. THERE WAS NO LEAKAGE WITH THE HOSE. THE SERVICE TECHNICIAN SUGGESTED CHANGING ALL USUAL WEARING PARTS. PRIOR TO REPAIR, THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATIONS BUT WAS OUTSIDE CALIBRATION AND SIDE TO SIDE SPECIFICATIONS AT THE ZERO THICKNESS SETTING. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY MEDICREA ON (B)(6) 2018 WHICH INCLUDED REPLACEMENT OF THE BALL BEARINGS, O-RINGS, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARING, VESPEL SLEEVE BEARING, POPPET HOUSING, POPPET SPRING, THROTTLE HINGE, THROTTLE HINGE GASKET, SEAL SCREW AND POPPET. AIR DERMATOME, SERIAL NUMBER (B)(4) WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED PER ZPO 13.90 REV. 41. THE REPORTED EVENT WAS NON-VERIFIABLE SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE AIR MOTOR WAS IN GOOD CONDITION WITH A GOOD TORQUE VALUE. PRIOR TO REPAIR, THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATIONS AND WAS ONLY OUTSIDE CALIBRATION AND SIDE TO SIDE SPECIFICATIONS AT THE ZERO THICKNESS SETTING. THE SERVICE TECHNICIAN SUGGESTED CHANGING ALL TYPICAL WEARING PARTS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE AIR MOTOR WAS IN GOOD CONDITION WITH A GOOD TORQUE VALUE. PRIOR TO REPAIR, THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATIONS AND WAS ONLY OUTSIDE CALIBRATION AND SIDE TO SIDE SPECIFICATIONS AT THE ZERO THICKNESS SETTING. THE SERVICE TECHNICIAN SUGGESTED CHANGING ALL TYPICAL WEARING PARTS. IT IS UNKNOWN WITH THE INFORMATION THAT WAS PROVIDED HOW THIS OCCURRED. 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 · 0

    THE DEVICE IS TAKING A THIN GRAFT EVEN IF ADJUSTED TO TAKE THICKER.

    Additional Manufacturer Narrative · 1

    THE EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ITEM WAS SHIPPED TO MAINTENANCE AS IT SEEMED TO NOT GRAFT THE SKIN AS IT SHOULD. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314383 ZMR AIR DERMATOME HANDPIECE DERMATOME GFD ZIMMER SURGICAL, INC. N/A 63130445

    Patients

    Seq Age Sex Outcome Treatment
    1