BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4975273 · Received August 5, 2015

    Report

    Report Number
    1719045-2015-10501
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Report Date
    July 22, 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

    A SERVICE AND REPAIR EVALUATION WAS PERFORMED ¿ THE CUSTOMER REPORTED THE MOTOR WOULD EITHER RUN CONTINUOUSLY OR NOT WORK AT ALL IF WET. THE REPAIR TECHNICIAN REPORTED THE MOTOR WAS RUNNING SLOW IN REVERSE AND FAST-FORWARD. MOTOR FAILURE IS 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 ON (B)(6) 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. DATE OF EVENT: UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER. 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. A REVIEW OF THE SERVICE HISTORY HAS BEEN REQUESTED. 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

    A SERVICE HISTORY REVIEW WAS PERFORMED ¿ LOT NO: 004687. A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 30-MAR-2015 DUE TO MOTOR FAILURE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 22-JUL-2015 AND REPORTED THAT THE DEVICE IS INOPERABLE-WON'T TURN OFF/UNINTENDED MOTION. THE PREVIOUS SERVICE CONDITION OF MOTOR FAILURE IS RELEVANT TO THE CURRENT COMPLAINED ISSUE OF DEVICE IS INOPERABLE-WON'T TURN OFF/UNINTENDED MOTION. THE MANUFACTURE DATE OF THIS ITEM IS 5-JUL-2012. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES CONSULTANT THAT ALL OF THESE HAND PIECE FOR BATTERY POWERED DRIVERS WERE TESTED IN THE SPD ROOM AT THE HOSPITAL. DETAILED DESCRIPTION OF ISSUE REPORTED: 003966: MOTOR IS DEAD. 005621: MOTOR WORKS INTERMITTENTLY, GEARS MAKE A ROUGH GRINDING NOISE. 002720: MOTOR SOUNDS BAD, GEARS MAKE A LOUD GRINDING NOISE. 004687: MOTOR EITHER DOESN'T WORK AT ALL OR RUNS CONTINUOUSLY IF THE UNIT GETS WET. 004506: MOTOR RUNS CONTINUOUSLY IF WET BUT RUNS OK WHEN IT IS DRY. 004527: MOTOR RUNS CONTINUOUSLY. ALL OF THESE WERE DISCOVERED DURING ROUTINE INSPECTION BY SALES REP, AND THAT THERE WAS NO CASE OR PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514829 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 004687

    Patients

    Seq Age Sex Outcome Treatment
    1