BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM TI ELASTIC NAIL 440MM

    MDR report key: 4734959 · Received April 28, 2015

    Report

    Report Number
    2520274-2015-13474
    Event Type
    Malfunction
    Date Received
    April 28, 2015
    Date of Event
    April 13, 2015
    Report Date
    April 13, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HTY
    PMA / PMN Number
    PK971783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE SURGEON CUT A PIECE OF THE NAIL OFF INTRA-OPERATIVELY ((B)(6) 2015). THE REMAINDER OF THE DEVICE REMAINS IMPLANTED IN THE PATIENT. A SMALL PORTION OF THE DEVICE WAS RETURNED ON APRIL 24, 2015. THE PRESENCE OF THIS PIECE WAS NOT DISCOVERED UNTIL THE INVESTIGATION WAS UNDERWAY AS IT WAS INSIDE THE INSERTION HANDLE. THEREFORE, AN AWARENESS DATE FOR THIS REPORT IS THE DATE THE INVESTIGATION WAS COMPLETED (JUNE 9, 2015). PRODUCT INVESTIGATION SUMMARY: ONE INSERTER, FOR TITANIUM ELASTIC NAILS (PART 359.219 / LOT 1811056) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿DOES NOT/WILL NOT FUNCTION: STICKS/JAMS/STUCK.¿ ONE 2.5MM TI ELASTIC NAIL, 440MM (PART 475.925, LOT NUMBER) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿BROKEN: INTRAOPERATIVELY.¿ IT WAS REPORTED THAT WHILE THE PATIENT WAS UNDERGOING AN ELASTIC NAILING SURGICAL PROCEDURE OF HER LEFT PROXIMAL HUMERUS, THE BACK OF THE TITANIUM ELASTIC NAIL (TEN) HANDLE BROKE OFF. AFTER THE TITANIUM NAIL WAS SEATED, A BOLT CUTTER WAS USED TO SEPARATE THE HANDLE FROM REST OF THE NAIL. THE COMPLAINT CONDITION IS CONFIRMED AS THE T-HANDLE OF THE INSERTER WAS BROKEN OFF AND THE ELASTIC NAIL IS STUCK IN THE INSERTER. THE BROKEN CONDITION, WHICH LIKELY RESULTED IN THE JAMMED CONDITION, IS A RESULT OF INADEQUATE STRENGTH OF THE T-HANDLE, WHICH IS BEING ADDRESSED. THE PIECE OF THE ELASTIC NAIL WAS RECEIVED STUCK IN THE CANNULATION OF THE INSERTER SUCH THAT THE PROXIMAL TIP OF THE NAIL WAS IN THE INSERTER AND A PORTION OF THE NAIL WAS EXTENDING OUT OF THE CHUCK OF THE INSERTER. THE MAJORITY OF THE ELASTIC NAIL WAS NOT RECEIVED AS IT WAS REPORTED TO HAVE BEEN SUCCESSFULLY IMPLANTED. THE INSERTER IS BROKEN SUCH THAT THE DISTAL T-HANDLE IS DETACHED FROM THE REMAINDER OF THE DEVICE. THERE ARE DENTS AND FLATTENING OF THE DISTAL END WHERE IMPACT FROM THE HAMMER WOULD OCCUR. THERE ARE ALSO SCRAPES AND DENTS TO THE DISTAL TIP AND BLUE HANDLE WHERE IMPACT WOULD NOT BE EXPECTED. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT THE CONDITION THAT RESULTED IN COMPLAINT CANNOT BE REPLICATED BECAUSE THE NAIL COULD NOT BE REMOVED FROM THE INSERTER AND THE DEVICES ARE ALREADY SEVERELY DAMAGED. DEVICE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED. 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 WHILE THE PATIENT WAS UNDERGOING AN ELASTIC NAILING SURGICAL PROCEDURE OF HER LEFT PROXIMAL HUMERUS, THE BACK OF THE TITANIUM ELASTIC NAIL (TEN) HANDLE BROKE OFF. NO ADDITIONAL INSTRUMENT WAS AVAILABLE AND THE DAMAGED INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. AFTER THE TITANIUM NAIL WAS SEATED, A BOLT CUTTER WAS USED TO SEPARATE THE HANDLE FROM REST OF THE NAIL. CURRENTLY A PIECE OF TITANIUM NAIL IS IN THE TEN HANDLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277728 2.5MM TI ELASTIC NAIL 440MM PIN,FIXATION,SMOOTH HTY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR