BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 56MM

    MDR report key: 6377015 · Received March 3, 2017

    Report

    Report Number
    2520274-2017-10724
    Event Type
    Injury
    Date Received
    March 3, 2017
    Report Date
    January 19, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HTY
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL DEVICE PRODUCT CODES JDW, JDS, JDN, HSB. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    IT WAS REPORTED THAT PATIENT HAD A FEMORAL NAIL IMPLANTED ON (B)(6) 2007. ON (B)(6) 2017 PATIENT UNDERWENT REVISION SURGERY DUE TO HYPERTROPHIC NONUNION. DURING THE REVISION SURGERY, ONE (1) NAIL AND FOUR (4) LOCKING BOLT SCREWS WERE REMOVED. PATIENT WAS REVISED WITH A LARGER FEMORAL NAIL. THERE WAS NO DELAY IN SURGERY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 4.9 MM TI LOCKING BOLT 56 MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159457 4.9MM TI LOCKING BOLT 56MM PIN, FIXATION, SMOOTH HTY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention