BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 HEXALOBE DRIVER-MALE

    MDR report key: 3083456 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10983
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 17, 2012
    Report Date
    July 17, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE TIP OF THE HEX DRIVER END IS DAMAGED AND THE ENDS ARE TWISTED. THE EVALUATION INDICATES THE REPORTED FAILURE IS NOT ASSOCIATED WITH THE MANUFACTURING.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED. DESIGN ASSESSMENT DETERMINED THAT THE MATERIAL IS APPROPRIATE FOR THIS APPLICATION. THE INSTRUMENT WAS USED TO REMOVE AN UNKNOWN NON-SYNTHES IMPLANT. THE TORQUE REQUIRED TO REMOVE THE IMPLANT IS UNKNOWN, AND IT IS ALSO UNCERTAIN IF THE PROPER DRIVER WAS USED. BASED ON THE COMPLAINT DESCRIPTION, ANOTHER INSTRUMENT WITH A DIFFERENT TIP WAS ALSO DAMAGED WHILE TRYING TO LOOSEN THE IMPLANT. THIS SUGGESTS THAT THE IMPLANT WAS STUCK AND REQUIRED UNUSUALLY HIGH TORQUE FOR REMOVAL. BASED ON THESE FACTORS, THIS COMPLAINT IS INDETERMINATE FROM A DESIGN PERSPECTIVE.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REMOVAL OF A POSTERIOR LUMBAR FUSION, AS THE PEDICLE SCREWS WERE BEING REMOVED ONE OR MORE SCREWS MAY NOT HAVE BEEN ABLE TO BE REMOVED. THE COMPLAINED INSTRUMENTS BROKE AS THE SURGEON WAS TRYING TO REMOVE THE SCREWS. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183814 T25 HEXALOBE DRIVER-MALE HXX SYNTHES MONUMENT 617271N09

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR