BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 10MM

    MDR report key: 7161403 · Received January 3, 2018

    Report

    Report Number
    2939274-2018-50055
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 6, 2017
    Report Date
    December 6, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    DZL
    UDI-DI
    10886982203700
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH AND WEIGHT NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODE: MQN. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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 THE HEAD BROKE OFF A SCREW DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT METACARPAL ON (B)(6) 2017. SURGEON WAS INSERTING THE SCREW IN A REASONABLE MANNER, USING LIGHT TWISTING MOTIONS. THE SHAFT AND THREADS OF THE SCREW REMAIN IN THE PATIENT. SURGEON IMPLANTED ANOTHER SCREW OF THE SAME SIZE NEXT TO THE BROKEN SCREW. SURGERY WAS DELAYED APPROXIMATELY 5 MINUTES. CONCOMITANT DEVICES REPORTED: SCREWDRIVER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5867 1.5MM TI CORTEX SCREW SELF-TAPPING 10MM SCREW FIXATION INTRAOSSEOUS DZL WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 400.810.96 10886982203700

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR