BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4592211 · Received March 11, 2015

    Report

    Report Number
    1719045-2015-10154
    Event Type
    Malfunction
    Date Received
    March 11, 2015
    Report Date
    February 27, 2015
    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

    SERVICE HISTORY REVIEW: LOT 003730/6156144/002761: A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON (B)(4) 2012 AND (B)(4) 2013 DUE TO MOTOR FAILURE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(4) 2015 AND REPORTED THE DEVICE IS INOPERABLE, RUNS CONTINUOUSLY. THE PREVIOUS SERVICE CONDITIONS OF MOTOR FAILURE ARE RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE DEVICE IS INOPERABLE, RUNS CONTINUOUSLY. THE SERVICE HISTORY EVALUATION IS CONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DEVICE WAS RUNNING CONTINUOUSLY. THE REPAIR TECHNICIAN REPORTED MOTOR FAILURE AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: CIRCUIT BOARD, MOTOR, MEMBRANE SWITCH/FLEX CIRCUIT, AND ALL APPLICABLE COMPONENTS. THIS ITEM WAS REPAIRED, PASSED SYNTHES FINAL INSPECTION AND RETURNED TO THE CUSTOMER. THE EVALUATION WAS CONFIRMED. HEALTH PROFESSIONAL INADVERTENTLY CHECKED; SHOULD BE ONLY COMPANY REPRESENTATIVE 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM 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 HAND PIECE FOR BATTERY POWERED DRIVER RUNS CONTINUOUSLY. COMPLAINT ISSUES FOR ALL DEVICES FOUND AFTER GOING THROUGH THE CLEANING PROCESS. THERE IS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED FOUR (4) HAND PIECES FOR BATTERY POWERED DRIVER. HAND PIECE ASSOCIATED WITH LOT NUMBER 005208, RUNS TOO SLOW IN FAST SPEED. HAND PIECE ASSOCIATED WITH LOT NUMBER 003730 RUNS CONTINUOUSLY. FOR HAND PIECES ASSOCIATED WITH LOT NUMBERS 001804 & 004587, THE MOTORS DO NOT WORK. COMPLAINT ISSUES FOR ALL DEVICES FOUND AFTER GOING THROUGH THE CLEANING PROCESS. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169417 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 6156144

    Patients

    Seq Age Sex Outcome Treatment
    1