BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3953927 · Received July 23, 2014

    Report

    Report Number
    8030965-2014-10421
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 26, 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

    SERVICE HISTORY REVIEW OF THE DEVICE HAS BEEN PERFORMED. THE REVIEW INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED DURING THE PAST 6 MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. THE INVESTIGATION IS BASED ON THE SERVICE & REPAIR RECORD (SRR) RECEIVED. 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 FOLLOWING ACTION TAKEN: REPAIR. THE DEVICE HAS BEEN SERVICED AND FUNCTIONAL TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH SERVICE MANUAL 532.021 - PRE-REPAIR DIAGNOSTIC ASSESSMENT/REPAIR VERIFICATION DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE SERVICE TECHNICIAN IDENTIFIED THE FOLLOWING FAILURE: MECHANICS SWING FORK BLOCKED. THE PROBABLE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER 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. 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. 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 THE SAW ATTACHMENT DOES NOT FUNCTION, THE BEARING IS REPORTED TO POSSIBLY BE WORN OUT. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431839 SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE SYNTHES OBERDORF

    Patients

    Seq Age Sex Outcome Treatment
    1