BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4361453 · Received December 24, 2014

    Report

    Report Number
    1719045-2014-10700
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Report Date
    November 26, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 15-OCT-2012, 25-APR-2013, 24-JUL-2013 AND 02-DEC-2013 DUE TO MOTOR FAILURE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 26-NOV-2014 AND REPORTED THE DEVICE IS INOPERABLE. THE PREVIOUS SERVICE CONDITIONS OF MOTOR FAILURE ARE RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE DEVICE IS INOPERABLE 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.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THE ITEM WAS WASHED IMPROPERLY AND NOW RUNS CONSTANTLY WHEN BATTERY IS ATTACHED. ISSUE WAS DISCOVERED AFTER CLEANING. THE MALFUNCTION DID NOT OCCUR DURING A PROCEDURE THEREFORE NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849753 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 004739

    Patients

    Seq Age Sex Outcome Treatment
    1