BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 3133158 · Received May 29, 2013

    Report

    Report Number
    1719045-2013-01480
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GZL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE ORIGINALLY RECEIVED ON 5/8/2013. THE DEVICE WAS RECEIVED NON-WORKING. THE DEVICE WAS RECEIVED AT SERVICE AND REPAIR WHO CONDUCTED A VISUAL EVALUATION AND DETERMINED THE DEVICE WAS REPAIRED AND SHIPPED BACK TO CUSTOMER ON 5/21/2013. THERE ARE NO KNOWN NCRS ASSOCIATED WITH THIS ITEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(4): THE ITEM WAS RECEIVED INOPERABLE. A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 13-JUL-2012 AND 14-SEP-2012 AND 15-FEB-2013 AND 17-APR-2013 DUE TO MOTOR FAILURE. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 29-APR-2013 FOR INOPERABLE DEVICE. THE PREVIOUS SERVICE CONDITIONS OF MOTOR FAILURE ARE RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4)

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE SERVICE AND REPAIR DEPARTMENT THAT THE HAND PIECE FOR BATTERY POWERED DRIVER WAS INOPERABLE. THIS COMPLAINT WAS 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 NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON PATIENT. THE REPORTED INSTANCE WAS NOT AN ANTICIPATED SERVICE OR WARRANTY REPLACEMENT ISSUE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235323 HAND PIECE FOR BATTERY POWERED DRIVER GZL SYNTHES MONUMENT 6159766

    Patients

    Seq Age Sex Outcome Treatment
    1