BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL ATTACHMEND MQC FOR PEN DRIVE

    MDR report key: 4012562 · Received August 15, 2014

    Report

    Report Number
    3009450871-2014-10331
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: NO VISIBLE DAMAGE; SIGNS OF NORMAL USAGE. A FUNCTIONAL TEST OF THE HAND-PIECE TOGETHER WITH THE MINI-QUICK-COUPLING HAS BEEN PERFORMED SUCCESSFULLY. THE COUPLING COULD BE ATTACHED AND WAS OPERATING WITHOUT ANY NOTICEABLE PROBLEM. THE COMPLAINT IS SPECIFICALLY REPORTED FOR A PROBLEM WITH THE HAND-PIECE OPERATING IN THE OFF POSITION. THE COUPLING IS NOT RELATED TO THE COMPLAINT ISSUE AND THEREFORE HAS NOT BEEN INVESTIGATED IN DETAIL. 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 CODE FOR THIS REPORT INCLUDES; DZI, ERL AND HBE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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: WEIGHT REPORTED AS OVERWEIGHT BUT NOT OBESE. 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: IT WAS REPORTED THAT DURING SURGERY FOR A NON UNION OF THE STERNUM THE E-PEN STARTED WORKING WHILE THE HAND PIECE WAS IN THE LOCK POSITION. THE E-PEN WAS ON THE PATIENT WHEN IT STARTED WORKING. FORTUNATELY, THERE WAS NO HARM TO EITHER THE PATIENT OR THE SCRUB PERSONAL. TO MAKE IT STOP WE HAD TO TURN THE E-PEN OFF AT THE POWERPOINT. THE E-PEN WAS PULLED APART AND PUT BACK TOGETHER BUT AS SOON AS IT WAS TURNED ON AT THE SWITCH THE SAME THING OCCURRED. NO HARM TO PATIENT AND NO REPORT OF ANY SURGICAL DELAY. THIS REPORT IS 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491261 DRILL ATTACHMEND MQC FOR PEN DRIVE INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE DEPUY SYNTHES POWER TOOLS 3781756

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR