BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 5857216 · Received August 9, 2016

    Report

    Report Number
    2520274-2016-13989
    Event Type
    Injury
    Date Received
    August 9, 2016
    Report Date
    July 21, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(6). THE EXACT DATE OF DEVICE BREAKAGE AND NON-UNION IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN BROKEN LOCKING SCREW. AT THIS TIME, THE EXACT PART NUMBER IS UNKNOWN, BUT IS LIKELY ONE OF THE FOLLOWING THREE: 04.005.420: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS ¿ HSB: ROD, FIXATION, INTRAMEDULLARY ¿ K103002, 04.005.424: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS ¿ HSB: ROD, FIXATION, INTRAMEDULLARY ¿ K103002, 04.005.430: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS ¿ HSB: ROD, FIXATION, INTRAMEDULLARY ¿ K103002. WITHOUT VERIFICATION OF THE EXACT PART NUMBER AND ITS ASSOCIATED LOT, THE UDI IS NOT AVAILABLE. PER FACILITY, THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURING REVIEW/INVESTIGATION. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NON-UNION AND BROKEN SCREW WERE DISCOVERED ON AN UNKNOWN DATE VIA AN X-RAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016. THE PATIENT PRESENTED WITH NON-UNION; IT WAS THEN CONFIRMED THAT ONE (1) OF THE IMPLANTED 4.0MM TITANIUM (TI) LOCKING SCREWS HAD BROKEN DISTALLY. DURING THE REVISION, A TI ADOLESCENT LATERAL FEMORAL NAIL AND THREE (3) SCREWS WERE REMOVED. A PORTION OF THE BROKEN SCREW REMAINED IN SITU. THE PATIENT WAS THEN REVISED WITH A PROXIMAL FEMUR HOOK PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A POST-OPERATIVE PATIENT OUTCOME OF STABLE. CONCOMITANT DEVICE(S) REPORTED: FEMORAL NAIL (PART: 04.031.934S / LOT: UNKNOWN / QUANTITY: 1), RECON SCREW (PART: 04.031.025 OR 04.031.028 / LOT: UNKNOWN / QUANTITY: 1), LOCKING SCREWS (PARTIAL PART: 04.005.4XX / LOT: UNKNOWN / QUANTITY: 2). THIS REPORT IS FOR ONE (1) UNKNOWN BROKEN TI LOCKING SCREW. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512560 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention