BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 4142172 · Received October 5, 2014

    Report

    Report Number
    3009450871-2014-10450
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PK043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION HAS BEEN PERFORMED OR 05.001.010 EPD 60000 RPM SN (B)(4) BY (B)(4) (TEAMLEAD SERVICE & REPAIR) AND (B)(4) SPIES (COMPLAINT HANDLING MANAGER) IN THE (B)(4) SERVICE CENTER PRODUCT HAS BEEN RECEIVED IN A STERILIZATION CASE TOGETHER WITH ATTACHMENTS. BASED ON THE REPORTED ISSUES THE INVESTIGATION IS LIMITED TO THE HANDPIECE ONLY. NO INVESTIGATION ON ATTACHMENTS REQUIRED. FIRST A FUNCTIONAL TEST WITHOUT MECHANICAL LOAD OF THE DEVICE HAS BEEN PERFORMED. TEST PASSED SUCCESSFULLY. POWER MEASUREMENT ON THE TEST BENCH HAS BEEN PERFORMED. TEST PASSED SUCCESSFULLY. FURTHERMORE THE PRODUCT WAS HANDED TO (B)(4) (SENIOR DEVELOPMENT ENGINEER) FOR FURTHER INVESTIGATION. THE COMPLAINT ISSUE WAS REPRODUCABLE. THE SENSOR HAS THEREFORE BEEN RECALIBRATED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE ARTICLE NUMBER (B)(4), SERIAL NUMBER (B)(4) WAS PACKAGED UNDER THE PRODUCTION ORDER (B)(4) IN WALDENBURG, WHICH WAS CONFIRMED ON (B)(4) 2013 AND RELEASED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NCRS WERE GENERATED OR NOTED DURING PRODUCTION IN THE PROCESS DOCUMENTATION/RECORDS. SERVICE HISTORY REVIEW FOR (B)(4), SN (B)(4)HAS BEEN PERFORMED. THE REVIEW INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED PREVIOUSLY. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. 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: IT WAS REPORTED THAT A SURGICAL DRILL CAN NOT BE POWERED OFF, INTERMITTENTLY, DUE TO A FAULTY ACTIVATION SWITCH. THE DRILL IS ACTIVATED USING A DETACHABLE HAND SWITCH. THE SWITCH MUST BE PRESSED DOWN TO OPERATE THE DRILL. WHEN THE SWITCH IS RELEASED, THE DRILL POWERS OFF. THE DEPARTMENT WHO REPORTED THE FAULT HAVE TWO DETACHABLE HAND SWITCHES WHICH ARE BOTH USED WITH DHE DRILL. PROBLEM: BOTH DETACHABLE HAND SWITCHES ARE INTERMITTENTLY STICKING IN TH "ON" POSITION, MAKING IT IMPOSSIBLE TO POWER THE DRILL OFF. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621823 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