BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4289037 · Received December 2, 2014

    Report

    Report Number
    1719045-2014-10648
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Report Date
    November 5, 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

    A SERVICE HISTORY MAINTENANCE REVIEW WAS PERFORMED AND THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE CUSTOMER REPORTED THE DEVICE WAS INOPERABLE. THE REPAIR TECHNICIAN REPORTED THE CONTACT PLATE WAS CRACKED, THE QC WAS STICKING, AND THE MOTOR WAS RUNNING INCONSISTENTLY. MOTOR FAILURE IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: CONTACT PLATE, CIRCUIT BOARD, MOTOR, MEMBRANE SWITCH/FLEX CIRCUIT, AND ALL APPLICABLE COMPONENTS. THIS ITEM WAS REPAIRED, PASSED FINAL INSPECTION AND RETURNED TO THE CUSTOMER ON 6-JAN-2015. THE EVALUATION WAS CONFIRMED. 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. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY MAINTENANCE REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE: SERVICE HISTORY REVIEW: LOT #002955/6184224 A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON (B)(6) 2013 AND THE DEVICE PASSED TESTING. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(6) 2014 AND REPORTED THE DEVICE IS INOPERABLE, RUNS SLOW. THE PREVIOUS SERVICE CONDITION OF THE DEVICE PASSED TESTING IS NOT RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE DEVICE IS INOPERABLE. THE MANUFACTURE DATE OF THIS ITEM IS (B)(6) 2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 THAT THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THE HAND PIECE FOR BATTERY POWERED DRIVER QUANTITY 2 STOPPED WORKING DURING ROUTINE TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WILL MADE AVAILABLE. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778669 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 6184224

    Patients

    Seq Age Sex Outcome Treatment
    1