BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS

    MDR report key: 5973304 · Received September 23, 2016

    Report

    Report Number
    2520274-2016-14664
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID: (B)(6). (B)(4). DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 WHILE PERFORMING AN INITIAL LEFT-HIP SURGERY ON (B)(6) 2016 THE SCREW HEAD BROKE OFF OF THE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS WHILE BEING INSERTED INTO THE 10MM/125 DEG TI CANNULATED TFNA 170MM-STERILE LOCKING NAIL. THE SHAFT OF THE SCREW WAS INSERTED INTO THE BONE OF THE PATIENT AS IT WAS INTENDED TO BE, BUT THE BROKEN PIECE OF THE SCREW HEAD CAME OUT OF THE PATIENT AND WAS DISPOSED OF AT THE HOSPITAL. THE SHAFT OF THE SCREW IS RETAINED IN THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF SURGICAL DELAY OR MEDICAL INTERVENTION. THE PATIENT'S POST-OPERATIVE STATUS WAS NOTED TO BE STABLE. THIS COMPLAINT HAS 1 DEVICE. CONCOMITANT DEVICE REPORTED: 10MM/125 DEG TI CANNULATED TFNA 170MM-STERILE, PART #-04.037.012S, LOT #-H150843. QUANTITY (1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624208 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 04.037.012S, 10MM/125 DEG TI CANNULATED TFNA 170MM