BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3173895 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03332
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    November 25, 2011
    Report Date
    November 25, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 ADDITIONAL EVALUATION REVEALED THAT MULTIPLE THREADS ARE BROKEN ON ALL THREE SCREWS. THE BREAK SURFACES ARE HOMOGENOUS AND DO NOT SHOW ANYTHING WHICH INDICATES PERFECT QUALITY OF THE MATERIAL. WE THINK THAT A TOO HIGH SIDE MECHANICAL STRESS LED TO THE BREAK OF THE THREAD. NO MATERIAL DEFECT IS PRESENT. A PRODUCT DEFECT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCREWS WERE DEFECTIVE AFTER FIRST USE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272953 EXTRACT-SCREW CONI F/SCR Ø2.7 3.5+4 HWB SYNTHES GMBH 2045

    Patients

    Seq Age Sex Outcome Treatment
    1