BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 6187338 · Received December 19, 2016

    Report

    Report Number
    3004608878-2016-00348
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    December 2, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 12/15/2016. METHOD: DEVICE HISTORY REVIEW; TREND ANALYSIS; FAILURE ANALYSIS. DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID S/N (B)(4) MANUFACTURED ON 11/28/2007 SHOW 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. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. MODEL S DERMATOME HAND PIECE SERIAL # (B)(4) WAS RECEIVED WITH A GUARD, FULL WIDTH CLIP SET INCLUDING THE 1¿ CLIP, FULL TOOL SET, AND A DERMATOME CORD. HAND PIECE WAS RECEIVED IN A NON-WORKING CONDITION, MAIN ISSUE SEEMS TO BE THE THUMB SWITCH IS STUCK AND WILL NOT MOVE. DURING INSPECTION CORROSION BUILD UP WAS FOUND INSIDE THE ACTUATOR ROD SHAFT. THE BUILDUP PREVENTS THE ROD FROM MOVING AND ACTIVATING THE MICRO SWITCH. THE HEAD WAS FOUND IN TOLERANCE ON ALL POINTS AND INTERNAL ASSEMBLIES ARE WORN FROM OVERUSE BUT ALL PASSED INSPECTION. IN SUMMARY, REASON FOR RETURN CONFIRMED. CORROSION BUILD UP INSIDE THE ACTUATOR ROD SHAFT CAUSED THE THUMB SWITCH TO BECOME STUCK. ONE YEAR IN SERVICE AT A BUSY BURN UNIT / TEACHING HOSPITAL IS EXCESSIVE TIME IN SERVICE. HOSPITAL HAS AGREED 3 TO 4 MONTHS IN SERVICE IS NORMAL FOR THIS ACCOUNT. INTEGRA REPRESENTATIVE WILL CONDUCT ANOTHER TRAINING SESSION AT THIS HOSPITAL.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 15DEC2016. THE INVESTIGATION ACTIVITIES INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID S/N (B)(4) MANUFACTURED ON 11/28/2007, SHOW 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. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. CONCLUSION - IN SUMMARY: REASON FOR RETURN CONFIRMED, CORROSION BUILD UP INSIDE THE ACTUATOR ROD SHAFT CAUSED THE THUMB SWITCH TO BECOME STUCK. ONE YEAR IN SERVICE AT A BUSY BURN UNIT / TEACHING HOSPITAL IS EXCESSIVE TIME IN SERVICE. HOSPITAL HAS AGREED 3 TO 4 MONTHS IN SERVICE IS NORMAL FOR THIS ACCOUNT. REFRESHER TRAINING FOR HOSPITAL STAFF PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE STARTS AND CUTS OFF INTERMITTENTLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837936 PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL S

    Patients

    Seq Age Sex Outcome Treatment
    1