BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT T15 F/DHS BLADE

    MDR report key: 3191200 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03238
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 9, 2011
    Report Date
    May 19, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE BROKEN FRAGMENT COULD BE IDENTIFIED AS PART OF AN INSTRUMENT. THE INVESTIGATION OF THE BROKEN SCREWDRIVER SHOWS CLEARLY EXCESSIVE APPLIED MECHANICAL FORCE AS ROOT CAUSE. THE TIP IS STRONGLY TWISTED WHAT INDICATES HIGH TORSIONAL FORCE IN ANTICLOCKWISE DIRECTION BEFORE THE BREAKAGE OCCURRED. THE BLADE DOES FUNCTION WELL. NO PRODUCT FAULT COULD BE IDENTIFIED.

    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. ADDITIONAL NARRATIVE: THE PATIENT WEIGHT WAS (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON FOUND THE METAL FRAGMENT IN THE PATIENTS BODY BY X-RAY, THE IMAGE WAS SHOWING SOME TINY METAL FRAGMENT. SO DURING THE REMOVAL SURGERY, HE RETRIEVED THE FRAGMENT. THE BONE FRAGMENT WAS HEALED, AND ON (B)(6) 2011 PROCEDURE FOR THE REMOVAL OF THE DHS SYSTEM. THE DOCTOR TRIED TO RELEASE THE LOCKED HELICAL BLADE. HE INSERTED THE DRIVER TO THE DHS BLADE, AND THEN TURNED, BUT COULD NOT TURN THE DRIVER, AND THEN HE TURNED THE DRIVER IN FORCE, SUDDENLY THE TIP OF THE SCREW DRIVER WAS BROKEN. AND THEN HE USED THE REMOVAL INSTRUMENT, AND HE SUCCEEDED TO REMOVE THE DHS SYSTEM. THERE WAS NOTHING LEFT IN THE PATIENT BODY. NO ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289768 SCRDRIVER SHAFT T15 F/DHS BLADE HXX SYNTHES GMBH 2250720

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR