BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 CANN W/HEX-COUPL Ø6

    MDR report key: 3182338 · Received June 21, 2013

    Report

    Report Number
    1719045-2013-01671
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 25, 2012
    Report Date
    June 20, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE COMPLAINED SCREW DRIVER SHAFT SHOWS THAT THE TIP IS COMPLETELY BROKEN OFF. THE REMAINING PART SHOWS A SLIGHTLY ANTI CLOCKWISE TWISTING, WHICH INDICATES THAT THE TIP MUST HAVE BROKEN OFF DURING IMPLANT REMOVAL. WE DO SUPPOSE THAT SIMPLY TOO MUCH MECHANICAL FORCE WAS USED WHICH LED TO THIS BREAKAGE. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE PRESENT INSTRUMENT WAS MANUFACTURED IN DECEMBER 2008 ACCORDING TO THE SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. CONCLUSION SINCE NO MANUFACTURING RELATED CONDITIONS WERE FOUND AND AS THIS IS A RATHER OLD AND OFTEN USED INSTRUMENT WE SUPPOSE THAT WEAR AND TEAR AFTER FREQUENT USE OVER THE YEARS COULD ALSO HAVE PLAYED A CERTAIN ROLE. NEVERTHELESS WE ARE PLEASED TO REPLACE THIS ARTICLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP WAS BROKEN AND THE BROKEN PART HAS BEEN DISPOSED OF. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282280 SCRDRIVERSHAFT T25 CANN W/HEX-COUPL Ø6 HXX SYNTHES MONUMENT 5807546

    Patients

    Seq Age Sex Outcome Treatment
    1