BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 4003496 · Received August 12, 2014

    Report

    Report Number
    1719045-2014-10373
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    July 17, 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

    (B)(4): ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INSTRUMENT WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE INNER SHAFT WAS BROKEN. WORN OUT PARTS IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: INNER SHAFT FOR EXTRACTION. THIS ITEM WAS REPAIRED, PASSED FINAL INSPECTION AND RETURNED TO THE CUSTOMER ON 4-NOV-2014.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. 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. NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER CANNOT BE TRACED. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A REVIEW OF THE DEVICE 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

    LOT #541391K04/4871022 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 15-OCT-2004. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED.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 THAT THE EXTRACTION SCREWDRIVER THE TIP WAS BROKEN OFF AND THE MATRIX HOLDING SLEEVE HAD A THREAD THAT WAS COMING UNDONE. THE ISSUE WAS DISCOVERED AFTER A SURGERY WAS COMPLETED WHILE THE SALES CONSULTANT WAS REFILLING A FEW PANS OF EQUIPMENT. WHILE REFILLING THEM AND LOOKING THROUGH THE INSTRUMENTS, IT WAS NOTED THAT A FEW INSTRUMENTS HAD BEEN BROKEN; IT IS NOT KNOWN HOW OR WHEN THEY WERE DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480404 EXTRACTION SCREWDRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 4871022

    Patients

    Seq Age Sex Outcome Treatment
    1