BEUDAMED
    FDA Adverse Event Injury Summary report: N

    END-CAP F/A2FN CANN EXTENS. 10 TAN GREY

    MDR report key: 4150815 · Received October 8, 2014

    Report

    Report Number
    1000562954-2014-10191
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    July 14, 2014
    Report Date
    September 11, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT AND EXPLANT DATES: DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION WE FOUND SIGNS OF DAMAGE AT THE THREAD AND AT THE HEAD CONNECTION OF THIS PART. WE ASSUME THIS WAS CAUSED BY INCORRECT ALIGNMENT DURING INSERTION AND/OR HAMMERING ON THE SCREWDRIVER WHILST ATTEMPTING INSERTION. A THOROUGH REVIEW OF THE MANUFACTURING DOCUMENTATION SHOWS THIS LOT MET ALL IN PROCESS AND RELEASE CRITERIA AT TIME OF PRODUCTION IN MAY 2014. MOREOVER A REVIEW OF OUR COMPLAINTS DATA BASE SHOWS NO OTHER COMPLAINTS FOR THIS ISSUE FROM THIS LOT NUMBER AND ARTICLE NUMBER. NO PRODUCT FAULT COULD BE DETERMINED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN ANTEGRADE FEMORAL NAIL (B)(6) WAS USED FOR A FRACTURE OF SHAFT OF FEMUR CASE. THE END CAP COULD NOT BE INSERTED INTO THE NAIL AT ALL DURING THE SURGERY. ALTHOUGH THE SURGEON ADDED SURGICAL INCISION TO CONFIRM THE NAIL DID NOT GET CAUGHT IN PATIENT¿S SOFT TISSUE, HE WAS NOT ABLE TO INSERT THE END CAP. THE SURGEON TRIED TO INSERT THE OTHER END CAP BUT WITHOUT SUCCESS. FINALLY HE DECIDED NOT TO INSERT AN END CAP AND COMPLETED THE SURGERY. THE SURGERY WAS EXTENDED FOR SIXTY MINUTES DUE TO THIS EVENT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632723 END-CAP F/A2FN CANN EXTENS. 10 TAN GREY ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MEZZOVICO 8882067

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention