BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II

    MDR report key: 3802002 · Received May 9, 2014

    Report

    Report Number
    8030965-2014-10230
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HBB
    PMA / PMN Number
    PK971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A FUNCTIONAL ASSESSMENT REVEALED THAT THE DEVICE FAILS TORQUE TEST, AND THE REVERSE TRIGGER WAS STUCK. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE USAGE WEAR OVER TIME. 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

    IT WAS REPORTED THAT DURING AN UNSPECIFIED ¿ORTHO¿ SURGICAL PROCEDURE, THE COMPACT AIR DRIVE DEVICE HAD INTERMITTENT POWER. THERE WAS A REPORTED DELAY OF TEN MINUTES TO THE PLANNED SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN, HOWEVER, THE REPORTER CLARIFIED THAT THE EVENT OCCURRED IN (B)(6) 2014. 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
    281703 COMPACT AIR DRIVE II MOTOR, DRILL, PNEUMATIC HBB SYNTHES OBERDORF 15600

    Patients

    Seq Age Sex Outcome Treatment
    1