BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACT-SCREW CONI F/SCR Ø4.5+6.5

    MDR report key: 3183589 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03770
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    July 7, 2011
    Report Date
    August 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE EXTRACTION SCREW WAS BROKEN DURING USE. THE INVESTIGATION OF THE COMPLAINED EXTRACTION SCREW SHOWS THAT IT WAS BROKEN DUE TO MECHANICAL OVERLOADING DURING USE. EXCEEDING APPLIED MECHANICAL FORCE, WELL BEYOND ITS CALCULATED DESIGN MAY HAVE CAUSED THE BREAKAGE OF THE TIP. WE ASSUME THAT THE LOCKING SCREW WAS COMPLETELY BLOCKED INSIDE THE LOCKING THREAD. MAYBE TOO STRONG TIGHTENING DURING INSERTION OR SOME INFLUENCE DURING THE HEALING PROCESS CAUSED FRETTING OF THE SCREW IN THE PLATE. THEREFORE A TOO HIGH MECHANICAL FORCE WAS APPLIED WHILE TRYING TO REMOVE THEM. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF A PLATE IT WAS NOTICED THAT THE SCREW WAS BROKEN. THE DOCTOR USED THE LARGE DRIVER, BUT THE HEXAGONAL TIP OF THE DRIVER WAS DEFORMED AND DRIVER COULD NOT FUNCTION ANYMORE. HE THEN USED A REMOVAL SCREW NEXT, AND WHEN HE LOADED THE TORQUE ON THE REMOVAL SCREW, THE REMOVAL SCREW BROKE. FINALLY HE USED A CARBIS DRILL. THE SCREW HEAD WAS REMOVED, BUT THE SCREW SHAFT WAS LEFT IN THE PATIENT. THE DOCTOR WAS WORRIED ABOUT THE SECONDARY BONE FRACTURE, SO HE DECIDED TO CLOSE THE WOUND. THE DOCTOR FEELS THERE IS A QUALITY PROBLEM WITH THE DRIVER. TIP OF THE DRIVER LOOKS SQUEEZED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284090 EXTRACT-SCREW CONI F/SCR Ø4.5+6.5 HWB SYNTHES GMBH 2711735

    Patients

    Seq Age Sex Outcome Treatment
    1