BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACT-SCREW CONI F/SCR Ø2.7 3.5+4

    MDR report key: 3193340 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02976
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    July 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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)(4). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE EXTRACTION SCREWS WERE DAMAGED DURING SURGERY. THE INVESTIGATION OF THE COMPLAINED EXTRACTION SCREWS HAS SHOWN THAT BOTH TIPS GOT DAMAGED- BROKEN. WE SUPPOSE THAT EXCEEDING APPLIED MECHANICAL FORCE, DURING REMOVAL OF THE SCREWS, WELL BEYOND ITS CALCULATED DESIGN MAY HAVE CAUSED THE BREAKAGE OF THE TIPS POSSIBLE STRONG TIGHTENING DURING INSERTION OR SOME INFLUENCE DURING THE HEALING PROCESS MAY HAVE CAUSED FRETTING OF THE SCREW IN THE PLATE. THE MANUFACTURING AND MATERIAL DOCUMENT SHOW NO DEVIATION TO THE SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTRACTION SCREWS WERE DAMAGED DURING SURGERY. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292738 EXTRACT-SCREW CONI F/SCR Ø2.7 3.5+4 HWB SYNTHES GMBH 2616287

    Patients

    Seq Age Sex Outcome Treatment
    1