BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URS Ø6 L45

    MDR report key: 3142491 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02615
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 17, 2011
    Report Date
    March 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED AND THE SCREW HEAD HAS DETACHED FROM THE BONE SCREW. WE DO SUPPOSED THE HEAD DETACHED FROM THE BONE SCREW UNDER EXTREME AXIAL FORCE. PLEASE NOT THAT IN SUCH CIRCUMSTANCES IT IS RECOMMENDED TO DISTRIBUTE THE FORCE ONTO BOTH SCREWS AS PER THE SURGICAL TECHNIQUE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WHILE EXTREME AXIAL FORCE MAY HAVE BEEN APPLIED TO THE SCREW WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM AND THE COMPLAINT CONDITION IS DUE TO THE CONDITION OF USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW HEAD HAS DISENGAGED FROM THE SCREW BODY AND THE TIP OF THE ANGLE IS BROKEN. PATIENT WAS TREATED WITH SCREWS ON THE RIGHT HAND SIDE AND THEN THE SURGEON PROCEEDED TO REDUCE THE SCREW AT L6 USING THE LOCKING CAP DRIVER AND COUNTER TORQUE. AT THAT POINT HE FELT A GIVE AND WHEN HE REMOVED THE COUNTER TORQUE HE NOTICED THAT THE WHOLE HEAD OF THE SCREW HAS COME AWAY FROM THE SCREW ITSELF. HE CONCLUDED THAT IT WAS BECAUSE HE SHOULD HAVE REDUCED BOTH RIGHT AND LEFT SIDES SIMULTANEOUSLY AND AFTER REMOVAL OF THE BROKEN SCREW AND INSERTION OF A SIMILAR REPLACEMENT SCREW, HE WAS ABLE TO REDUCE THE SLIP BY DOING SO. THE BROKEN SCREW, ALONG WITH THE LOCKING CAP WAS REMOVED COMPLETELY WITHOUT INCIDENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244195 URS Ø6 L45 HWC SYNTHES GMBH 3646322

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR