BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 6818072 · Received August 24, 2017

    Report

    Report Number
    0001526350-2017-00557
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Report Date
    October 23, 2017
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (B)(4). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION BECAUSE [IT WAS EVALUATED BY AN EXTERNAL CONTRACTOR. HOWEVER, THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT EVALUATED BY EXTERNAL CONTRACTOR.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ON AUGUST 11, 2017, IT WAS REPORTED THAT THE DERMAL CUT WAS FRACTIONATED AND THE PRODUCT DOES NOT CUT IN ONE PIECE. THE CUSTOMER RETURNED AN ELECTRIC DERMATOME DEVICE, SERIAL NUMBER 203533, FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN) OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS PREVIOUSLY REPAIRED/EVALUATED ELECTRIC DERMATOME SERIAL NUMBER (B)(4) TWO TIMES AS DOCUMENTED IN THE VDOC SERVICE PORTAL. THE LAST REPAIR WAS (B)(6), 2016 WHERE IT WAS REPORTED THAT THERE WAS A FAILURE AND THE BALL BEARING, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARING, VESPEL SLEEVE BEARING, MOTOR AND SWITCH WERE REPLACED. THIS IS NOT A RELATED ISSUE. INITIAL QA INSPECTION OF THE ELECTRIC DERMATOME BY MEDICREA ON AUGUST 24, 2017 REVEALED THAT THE MOTOR WAS WORN OUT AND COMPLETELY CORRODED. THE POWER CORD WAS IN VERY POOR CONDITION AND THE CONTROL BAR DID NOT CONFORM TO THE INPUT TESTS. THE RECIPROCATING ARM WAS ALSO WORN. REPAIR OF THE ELECTRIC DERMATOME WAS NOT PERFORMED BY MEDICREA AS THE CUSTOMER REQUESTED THAT THEIR DEVICE BE DESTROYED AND THEIR ACCESSORIES BE RETURNED. THE REPORTED EVENT WAS NON-VERIFIABLE AS NO TESTING WAS ABLE TO BE PERFORMED TO TRY TO REPLICATE THE REPORTED EVENT. HOWEVER, DURING THE INITIAL INSPECTION BY MEDICREA IT WAS NOTED THAT THE MOTOR WAS WORN OUT AND COMPLETELY CORRODED. THE POWER CORD WAS IN VERY POOR CONDITION AND THE CONTROL BAR DID NOT CONFORM TO THE INPUT TESTS. THE RECIPROCATING ARM WAS ALSO WORN. THE REPORTED EVENT WAS NON-VERIFIABLE AS NO TESTING WAS ABLE TO BE PERFORMED TO TRY TO REPLICATE THE REPORTED EVENT. HOWEVER, DURING THE INITIAL INSPECTION BY MEDICREA IT WAS NOTED THAT THE MOTOR WAS WORN OUT AND COMPLETELY CORRODED. THE POWER CORD WAS IN VERY POOR CONDITION AND THE CONTROL BAR DID NOT CONFORM TO THE INPUT TESTS. THE RECIPROCATING ARM WAS ALSO WORN. HENCE, A ROOT CAUSE CANNOT BE SPECIFICALLY DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. ELECTRIC DERMATOME, SERIAL NUMBER (B)(4), WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DERMAL CUT WAS "FRACTIONATED." THE PRODUCT DOES NOT CUT IN ONE PIECE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598598 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 60951934

    Patients

    Seq Age Sex Outcome Treatment
    1