BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II

    MDR report key: 3981806 · Received August 5, 2014

    Report

    Report Number
    8030965-2014-10446
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE DEVICE FAILURE REPORTED BY THE CUSTOMER COULD BE CONFIRMED. THE SERVICE HISTORY REVIEW SHOWS NO PREVIOUS SERVICE CONDITIONS RELEVANT TO THE CURRENT COMPLAINT ISSUE. THE SERVICE TECHNICIAN NOTED THE ACTION TAKEN AS REPAIR. THE DEVICE HAS BEEN SERVICED AND FUNCTIONAL TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH THE SERVICE MANUAL. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE SERVICE TECHNICIAN IDENTIFIED THE FAILURE CODE AS TRIGGER / SLIDER BLOCKED, JAMMED. ADDITIONAL SERVICE FAILURE DESCRIPTION: TOP TRIGGER DEFECT (REVERSE MODE): STICKS IN ON-POSITION. THE SERVICE TECHNICIAN IDENTIFIED THE PROBABLE ROOT CAUSE AS NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. 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

    SUBJECT DEVICE HAS BEEN RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A SERVICE HISTORY MAINTENANCE REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE DEVICE HAS NOT BEEN SERVICED DURING THE PAST 6 MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. 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 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. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE DOES NOT FUNCTION. THE TOP SWITCH OF DEVICE IS STUCK. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458514 COMPACT AIR DRIVE II INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES OBERDORF

    Patients

    Seq Age Sex Outcome Treatment
    1