BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 4932628 · Received July 22, 2015

    Report

    Report Number
    1719045-2015-10466
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    July 9, 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

    ADDITIONAL DEVICE PRODUCT CODE IS GXL. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE SERVICE HISTORY RECORDS 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

    SERVICE/ MAINTENANCE - EVAL ¿ THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE CUSTOMER REPORTED THE DEVICE WOULD WORKING INTERMITTENTLY. THE REPAIR TECHNICIAN REPORTED THE MOTOR WOULD NOT TURN. 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 4-AUG-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. A SERVICE HISTORY RECORD REVIEW OF THE PAST THREE YEARS WAS PERFORMED FOR THE SUBJECT DEVICE. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 17-OCT-2013 DUE TO MOTOR FAILURE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 9-JUL-2015 AND REPORTED THAT THE DEVICE IS INOPERABLE-RUNS INTERMITTENTLY. THE PREVIOUS SERVICE CONDITION OF MOTOR FAILURE IS RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE DEVICE IS INOPERABLE-RUNS INTERMITTENTLY. THE MANUFACTURE DATE OF THIS ITEM IS 6-MAR-2013. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS CONFIRMED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 ONE HAND PIECE FOR BATTERY POWERED DRIVER, LOT 004767, DOES NOT RUN IN REVERSE AND A SECOND HAND PIECE FOR BATTERY POWERED DRIVER, LOT 005864, IS WORKING INTERMITTENTLY. BOTH ISSUES WERE DISCOVERED DURING ROUTINE TESTING AND THERE WAS NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476087 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 004470-1

    Patients

    Seq Age Sex Outcome Treatment
    1