BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 3081456 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-02011
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 30, 2013
    Report Date
    March 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A SURGERY TO INSERT AN ELASTIC NAIL ON (B)(6) 2013, THE SURGEON HIT THE END OF THE INSERTER FOR TI ELASTIC NAIL WITH THE MALLET PER THE PROCEDURE. WHEN HE DID, A PIECE OF THE INSERTER CHIPPED OFF AND BECAME EMBEDDED IN THE SURGEONS FOREHEAD. A STAFF SURGEON REMOVED THE PIECE FROM THE SURGEONS FOREHEAD AND SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. PATIENT AND SURGEON REPORTED TO BE DOING WELL. THIS REPORT ADDRESSES THE SURGEON. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183624 INSERTER FOR TI ELASTIC NAILS LXH SYNTHES GMBH 3084637

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention