BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE Ø2.8 W/THREAD-TIP W/TROCAR L30

    MDR report key: 3163623 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02862
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    November 15, 2011
    Report Date
    November 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LRN
    PMA / PMN Number
    PREAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. ADD'L PRO CODE: JDW. (B)(6). A DHR REVIEW SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE MEASURABLE DIMENSION OF THE RETURNED GUIDE WIRE WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH THE SPECIFICATION AND WITHIN THE INTERNATIONAL STANDARD. AS NO DETAILED CLINICAL INFORMATION IS AVAILABLE, IT CAN ONLY ASSUME THAT THE GUIDE WIRE HAD BEEN SCREWED IN TOO MUCH (POSSIBLE HARD BONE) AND BROKE APART DURING RESITE OR REMOVAL AS FAR TOO MUCH MECHANICAL FORCE HAD TO BE APPLIED (VISIBLE DAMAGES AT THE BREAKAGE POINT). NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE GUIDE WIRE PASSED VIA MP JOINT ON THE LEFT FOOT UP 1ST METATARSAL AND INTO TALUS WITHOUT MUCH TROUBLE. THE GUIDE WIRE NEEDED TO BE RESET AND COULD NOT BE REMOVED. THE GUIDE WIRE BROKE OUTSIDE BONE AND LATER FULLY REMOVED WITH DIFFICULTY. SURGICAL TIME WAS PROLONGED DUE TO PRODUCT FAILURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264196 GUIDEWIRE Ø2.8 W/THREAD-TIP W/TROCAR L30 LRN SYNTHES GMBH 7574106

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR