BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 3690101 · Received March 20, 2014

    Report

    Report Number
    1719045-2014-10088
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Report Date
    February 21, 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 USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE OF GXL. DEVICE IS AN INSTRUMENT AND NOT AN IMPLANT/ EXPLANT. SERVICE HISTORY REVIEW: LOT #001942 A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE 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.

    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. ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE REPAIR TECHNICIAN REPORTED MOTOR FAILURE AS THE REASON FOR REPAIR. THE CAUSE OF THE MOTOR FAILURE IS UNKNOWN. THE CIRCUIT BOARD, MOTOR, AND MEMBRANE SWITCH/FLEX CIRCUIT WERE REPLACED AS WELL AS ALL APPLICABLE COMPONENTS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MOTOR FAILURE WAS REPORTED AS THE REASON FOR REPAIR. THE CAUSE OF THE MOTOR FAILURE IS UNKNOWN. THE CIRCUIT BOARD, MOTOR, AND MEMBRANE SWITCH/FLEX CIRCUIT WERE REPLACED AS WELL AS ALL APPLICABLE COMPONENTS. THIS ITEM WAS REPAIRED AND PASSED FINAL INSPECTION ON 17-MAR-2014 AND RETURNED TO THE CUSTOMER ON 20-MAR-2014. 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

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED A HAND PIECE FOR BATTERY POWERED DRIVE RUNNING SLOW. NO NEGATIVE IMPACT TO THE PATIENT. NO DELAY. ANOTHER WAS AVAILABLE IN THE ROOM TO USE. THIS IS NOT FOR A WARRANTY REPLACEMENT ONLY. THIS EVENT DID NOT CONTRIBUTE TO A DEATH OR INJURY, WHETHER THE DEVICE WAS MISUSED OR NOT. THE DEVICE DID MALFUNCTION DURING SURGERY WHILE BEING USED ON PATIENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167640 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 001942

    Patients

    Seq Age Sex Outcome Treatment
    1