BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.3MM TI CORTEX SCREW SELF-TAPPING 12MM

    MDR report key: 7022845 · Received November 10, 2017

    Report

    Report Number
    1719045-2017-11166
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 18, 2017
    Report Date
    October 19, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL DEVICE PRODUCT CODE: MQN. (B)(4). DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT FULLY IMPLANTED OR EXPLANTED. COMPLAINANT DEVICE 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FINGER FRACTURE REPAIR PROCEDURE ON (B)(6) 2017, THE SURGEON WAS IMPLANTING THE 1.3 MM TITANIUM (TI) CORTEX SCREW SELF-TAPPING 12 MM AND WHILE APPLYING FINAL TORQUE FOR TIGHTENING THE HEAD POPPED OFF LEAVING THE SHAFT OF THE SCREW IN THE BONE. THE SCREW HEAD WAS EASILY REMOVED. THE SURGEON WAS NOT ABLE TO REMOVE THE SHAFT AND THEREFORE WAS NOT ABLE TO PUT ANOTHER SCREW IN FOR DESIRED FIXATION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME IS GOOD. CONCOMITANT DEVICES REPORTED: UNKNOWN INSTRUMENT (QUANTITY # 1). THIS REPORT IS FOR ONE (1) 1.3 MM TI CORTEX SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796045 1.3MM TI CORTEX SCREW SELF-TAPPING 12MM SCREW,FIXATION,BONE HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR