BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTION HOOK - STERILE FOR TI CANNULATED NAILS

    MDR report key: 2874622 · Received December 15, 2012

    Report

    Report Number
    1719045-2012-01373
    Event Type
    Injury
    Date Received
    December 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH NAIL, BLADE AND LOCKING BOLTS ON (B)(6) 2012. IT WAS DISCOVERED ON AN UNKNOWN DATE, THE NAIL BROKE AT THE HELICAL BLADE. SURGEON NOTED THE PATIENT HAS HAD CANCER AND IT LOOKED LIKE THE BONE HEALED BELOW THE NAIL. THE AREA THAT HAD THE CANCER RADIATION TREATMENT WAS THE AREA WHERE THE BONE DID NOT HEAL. THE SURGEON FELT THE NON-UNION AND THE MYELOMA CANCER WERE THE CAUSE. THE NAIL BLADE AND LOCKING BOLTS WERE REMOVED ON (B)(6) 2012. PATIENT WAS REVISED TO A NEW 12MM NAIL SYSTEM. SURGEON IS PLEASED WITH THE RESULTS. DURING THE PROCEDURE THE EXTRACTION HOOK KEPT SLIPPING OFF THE DISTAL SIDE OF THE NAIL DELAYING THE PROCEDURE BY APPROXIMATELY ONE HOUR. THIS IS 5 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTION HOOK - STERILE FOR TI CANNULATED NAILS EXTRACTION HOOK HSB SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention NAIL, HOOK