BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY

    MDR report key: 3708753 · Received March 28, 2014

    Report

    Report Number
    1719045-2014-10110
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Report Date
    February 27, 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 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 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 #003623 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 MANUFACTURE DATE OF THIS ITEM IS AUGUST 3, 2010. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. ADDITIONAL EVALUATION STATES THAT THE ITEM WAS REPORTED TO BE RUNNING SLOW AND HARD TO START. THE ISSUE COULD NOT BE REPRODUCED. IT WAS REPORTED THAT PREVENTIVE MAINTENANCE WAS THE REASON FOR REPAIR. THE CONTACT PLATE, 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 (B)(6) 2014 AND WAS RETURNED TO THE CUSTOMER ON (B)(6) 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 THE (B)(4) (LOT 6217406): NOT WORKING AT ALL AND ALL THE REST ARE RUNNING SLUGGISH AFTER THEY FINALLY START RUNNING. NO NEGATIVE IMPACT TO ANY PATIENT. SLOWED THE SURGERY DOWN BY A COUPLE OF MINUTES DUE TO THE SLOW RUNNING ITEM. ALL SURGERIES WERE STERNAL PLATING. 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 4 DEVICES. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184030 HAND PIECE FOR BATTERY SCREWDRIVERS HXX SYNTHES MONUMENT 003623

    Patients

    Seq Age Sex Outcome Treatment
    1