BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 4920816 · Received July 17, 2015

    Report

    Report Number
    8030965-2015-11140
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Report Date
    April 20, 2015
    Manufacturer
    SYNTHES OBERDORF
    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

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    REPORTER¿S PHONE NUMBER: (B)(6). THERE WAS NO CONTACT¿S NAME PROVIDED. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE CONTROL UNIT AND MOTOR WERE NOT FUNCTIONING AND DEFECTIVE. IT WAS FURTHER DETERMINED THAT THE HOUSING WAS DISTORTED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE ELECTRIC PEN DRIVE DEVICE HAD AN UNSPECIFIED DEFECT. ACCORDING TO THE REPORTER, THERE WAS AN ISSUE WITH THE DEVICE MOTOR. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE CONTROL UNIT WAS NOT FUNCTIONING AND WAS DEFECTIVE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO DELAYS TO A SCHEDULED SURGICAL PROCEDURE. A SPARE DEVICE WAS NOT AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466971 EPD 60000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1