BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3173943 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03350
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2011
    Report Date
    May 9, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE ADDITIONAL EVALUATION REVEALED THAT THE INVESTIGATION CARRIED OUT ON THE SCREWDRIVER IN QUESTION SHOWED THAT THE TIP BROKE OFF COMPLETELY AS A RESULT OF EXCESSIVE TORSION STRESS. THE CAP IS SLIGHTLY DAMAGED. WE SUPPOSE THAT THE TIP BROKE OFF FINALLY. THE BROKEN SURFACE IS HOMOGENEOUS, WHICH POINTS TO A FLAWLESS MATERIAL QUALITY. EVEN THE INVESTIGATION OF THE MANUFACTURE DATA AND THE HARDNESS SPECIFICATIONS DID NOT RESULT IN ANY DEVIATIONS OF THE SPECIFICATIONS. NO PRODUCT ERROR WAS DETECTED.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWDRIVER TIP T 25, BROKE OFF DURING TIGHTENING OF THE URS SCREW. ALL PARTS HAVE BEEN RETRIEVED. THE SURGERY COULD BE FINISHED WITHOUT ANY PROBLEMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274474 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3694121

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR