BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 5990446 · Received September 30, 2016

    Report

    Report Number
    2520274-2016-14746
    Event Type
    Injury
    Date Received
    September 30, 2016
    Report Date
    September 13, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT NOT PROVIDED FOR REPORTING. UNKNOWN WHEN NON-UNION OCCURRED. OTHER: UDI: UNKNOWN PART NUMBER, UNKNOWN LOT NUMBER, UDI IS UNAVAILABLE. THIS REPORT IS FOR UNK - SCREW LOCKING/UNKNOWN LOT NUMBER. NOT EXPLANTED, STILL IN PATENT'S BODY. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE 510K#: UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 ON (B)(6) 2016, A PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL, HELICAL BLADE AND DISTAL LOCKING SCREW. ON AN UNKNOWN DATE, AN X-RAY REVEALED A NONUNION AND BROKEN LOCKING SCREW. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2016 FOR THE REMOVAL OF THE HARDWARE AND WAS REPLACED WITH A COMPETITOR'S HIP REPLACEMENT SYSTEM. IT WAS NOTED THAT HALF OF THE LOCKING SCREW WAS LEFT IN THE PATIENT AND THE SURGEON DID NOT ATTEMPT TO TAKE IT OUT BECAUSE IT WAS NOT IN THE WAY OF THE NEW DEVICES. IT WAS REPORTED THAT THE SURGERY WENT AS PLANNED, WITHOUT DELAY, AND THE PATIENT WAS STABLE. THIS COMPLAINT IS FOR ONE DEVICE. CONCOMITANT DEVICES: TROCHANTERIC FIXATION NAIL (PART # 456.416, LOT #9890670, QUANTITY 1) AND HELICAL BLADE (PART #456.305, LOT #9953840). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642889 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 456.305, HELICAL BLADE| 456.416, TROCHANTERIC FIXATION NAIL