BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE 1.1 W/THREAD-TIP W/TROCAR L15

    MDR report key: 2885085 · Received December 11, 2012

    Report

    Report Number
    8030965-2012-01534
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LRN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    (B)(4): THE MEASURABLE DIMENSIONS OF THE DRILL BIT AND GUIDE WIRE WERE CHECKED AND FOUND TO BE WITHIN SPECIFICATIONS. BASED ON THE PROVIDED DETAILS WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF FAILURE. WE CAN ONLY ASSUME THAT CONTACT WITH OTHER METALLIC MATERIALS LED TO AN INSTANTANEOUS APPLICATION OF MECHANICAL OVERLOAD AND HENCE TO THE BREAKAGE OF THE INVOLVED ARTICLES. NO PRODUCT FAULT COULD BE DETECTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A LISFRANC ARTHRODESIS PROCEDURE, THE DRILL BIT BROKE WHILE DRILLING OVER THE K-WIRE. MOST OF THE BROKEN FRAGMENTS WERE RETRIEVED BUT SOME BROKEN FRAGMENTS REMAINS IN THE PT. IT WAS REPORTED THE GUIDE WIRE ALSO BROKE DURING THE PROCEDURE. ALL BROKEN FRAGMENTS COULD NOT BE REMOVED. THE SURGICAL PLAN WAS CHANGED AND THE PT WAS IMPLANTED WITH PLATES AND SCREWS INSTEAD OF THE IM NAIL. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDEWIRE 1.1 W/THREAD-TIP W/TROCAR L15 GUIDE WIRE LRN SYNTHES GMBH 7824716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DRILL BIT