BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II

    MDR report key: 3812655 · Received May 15, 2014

    Report

    Report Number
    8030965-2014-10245
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HBB
    PMA / PMN Number
    PK971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE DEVICE FAILED THE TORQUE TEST. THEREFORE, THE REPORTED CONDITIONS WERE CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MECHANICAL COMPONENTS DAMAGED FROM NORMAL USE 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 SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE COMPACT AIR DRIVE DEVICE HAD A ¿STICKY TRIGGER¿ AND WOULD RUN EVEN AFTER THE TRIGGER HAD BEEN RELEASED. THE REPORT FURTHER INDICATED THAT THE DEVICE FELT LIKE THERE WAS NOT ENOUGH POWER "WHEN REAMING". THERE WAS A TEN MINUTE DELAY TO THE PLANNED SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    291258 COMPACT AIR DRIVE II MOTOR, DRILL, PNEUMATIC HBB SYNTHES OBERDORF 23798

    Patients

    Seq Age Sex Outcome Treatment
    1