BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 6590882 · Received May 25, 2017

    Report

    Report Number
    3004608878-2017-00170
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    January 27, 2017
    Report Date
    May 15, 2017
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON JUNE 16, 2017. RESULTS: EVALUATION OF RETURNED DEVICE; INVESTIGATION SITE RECEIVED MODEL B 110V DERMATOME KIT WHICH INCLUDES THE HAND PIECE (1-7096), POWER SUPPLY (1-RP-491), WIDTH CLIP SET (2¿,3¿,4¿ W/C), AND THE TOOL SET (CALIBRATION GAUGE, SCREWDRIVER). HP (0.55) AND PS (14.6) PASSED THE FUNCTION TEST, THE PS IS A NEWER UNIT AND IN GOOD CONDITION BUT THE HP IS 26+ YEARS OLD. BOTH UNITS HAVE BEEN IN SERVICE FOR 8+ MONTHS. MOST OF THE INTERNAL ASSEMBLIES HAVE NORMAL WEAR AND NEED PM SERVICE. DURING THE EVALUATION IT WAS FOUND A FEW ISSUES STARTING WITH CORROSION ON THE MALE PLUG, SCRATCH AND NICKS TO THE EXTERNAL ASSEMBLIES, AND A MINOR DING ON THE LEADING EDGE OF THE GAUGE BAR. HEAD CALIBRATION WAS FOUND IN-TOLERANCE ON ALL POINTS WITH HEAD PASSING ALL VISUAL AND DIMENSIONAL INSPECTIONS. WIDTH CLIP SET IS OLD STYLE AND WORN, ENGRAVING IS GONE AND ANODIZING IS WORN. THE REASON FOR RETURN COULD NOT DUPLICATE, BUT IT COULD BE POSSIBLE THAT EITHER THE WORN WIDTH CLIPS OR THE SHARP EDGE CREATED BY THE GAUGE BAR NICK COULD HARM THE GRAFT QUALITY. COMPLAINT DESCRIPTION ONLY STATES THE DERMATOME CAUSED AN INJURY BUT DOES NOT CALL OUT THE TYPE OF INJURY SUCH AS A CUT IN THE GRAFT OR THICKNESS OF GRAFT. ALTHOUGH THE NICK IS SMALL THE LOCATION OF THE DAMAGE AND THE SHARP EDGE CREATED COULD BE AN ISSUE. DHR REVIEW; NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. COMPLAINTS HISTORY; A TWO YEAR LOOKBACK FROM 06/15/2015 TO 06/15/2017 FOR THIS REPORTED FAILURE USING KEY WORDS "INJURY" FOR PRODUCT ID SHOWS THAT 2 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: REASON FOR RETURN, NOT CONFIRMED. TWO ISSUES WERE NOTED DURING THE EVALUATION. THE WIDTH CLIP SET IS OLD STYLE, WORN, AND OUT OF FLATNESS SPEC. ANY ONE OF THE W/C COULD HAVE CAUSED A THICKNESS LARGER OR SMALLER THAN THE ONE EXPECTED. IT WAS ALSO FOUND A SMALL NICK LOCATED IN THE MIDDLE OF THE LEADING EDGE OF THE GAUGE BAR. THE NICK IS SMALL BUT HAS A SHARP EDGE THAT COULD DAMAGE THE GRAFT. END-USER DID NOT SPECIFY THE NATURE OF THE INJURY, INVESTIGATORS COULD NOT CONFIRM EITHER ISSUE WOULD HAVE DAMAGED THE GRAFT OR INJURED THE PATIENT DURING THE PROCEDURE. THE UNIT WAS IN SERVICE FOR 8+ MONTHS WITHOUT INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPLIT THICKNESS SKIN GRAFT IN RIGHT DISTAL LEG 4.5CM X 3.5CM (EXCISION 14MM SQUAMOUS CELL CARCINOMA IN SITU RIGHT PROXIMAL LEG), A FULL THICKNESS LACERATION OF THE LEG OCCURRED. A SPLIT-THICKNESS SKIN GRAFT WAS ATTEMPTED TO BE HARVESTED FROM THE RIGHT ANTERIOR THIGH WITH A PADGETT ELECTRIC DERMATOME. THE INITIAL ATTEMPTS CREATED A SKIP INJURY. THE DERMATOME WAS DISASSEMBLED, A NEW BLADE WAS POSITIONED AND A SECOND ATTEMPT WAS COMPLETED. THE SECOND ATTEMPT RESULTED IN A FULL-THICKNESS LACERATION OF THE LEG. THE DERMATOME WAS DISCARDED FROM THE FIELD. THE 3.5CM FULL THICKNESS INJURY WAS REPAIRED WITH A 3.0 MONOCRYL DERMAL FAT APPROXIMATING SUTURE. A 4.0 MONOCRYL INTRACUTICULAR CLOSURE WAS COMPLETED. A WECK HAND HELD DERMATOME WITH A 0.12-INCH GUARD WAS UTILIZED TO FREE HAND A SKIN GRAFT. HEALING STATUS UNKNOWN, PT. WAS DISCHARGED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373220 MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT SKIN GRAFT PRODUCTS GFD INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention