BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3999854 · Received August 11, 2014

    Report

    Report Number
    3009450871-2014-10326
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 14, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PK043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: DZI, ERL, HBE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SERVICE HISTORY REVIEW OF THE DEVICE 05.001.010 EPD 60000 RPM SERIAL NUMBER (B)(4) HAS BEEN PERFORMED. THE REVIEW INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED IN THE PAST. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED WITH NO SIGNS OF DAMAGE VISIBLE, ONLY NORMAL USAGE. A FUNCTIONAL TEST OF THE DEVICE HAS BEEN PERFORMED SUCCESSFULLY. THE HAND-PIECE WITHOUT ATTACHMENT HAS BEEN OPERATED FOR SEVERAL MINUTES. NO EXCESSIVE HEAT EMISSION COULD BE OBSERVED DURING NORMAL OPERATION. POWER MEASUREMENT ON THE TEST BENCH HAS BEEN PERFORMED. ALSO UNDER LOAD THE HAND-PIECE DID NOT HEAT UP EXCESSIVELY. TEST PASSED SUCCESSFULLY. THE COMPLAINT ISSUE THAT THE HAND-PIECE IS GETTING TOO HOT COULD NOT BE CONFIRMED. IT WAS NOTED THAT VIBRATION AND NOISE WAS NOTICEABLE DURING OPERATION MOST LIKELY CAUSED BY LACK OF MAINTENANCE. THE TOOL HAS NOT BEEN SERVICED IN THE PAST THREE YEARS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2014, IT WAS DISCOVERED THAT A PATIENT HAD A BURN ON THE ARM WHICH ALLEGEDLY HAPPENED IN THEATRE THE DAY PRIOR ((B)(6) 2014). THE SURGEON THINKS THAT IT WAS DUE THE HEAT BUILDUP IN THE ELECTRONIC PEN WHICH HE WAS USING AND HAD TO PUT DOWN AS IT WAS GETTING TOO HOT TO HOLD. THERE WAS NO DELAY IN SURGERY. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476068 ELECTRIC PEN DRIVE 60,000 RPM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention