BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM

    MDR report key: 6943980 · Received October 12, 2017

    Report

    Report Number
    3000270450-2017-10357
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 27, 2017
    Report Date
    September 27, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S IDENTIFIER, DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE: HRS (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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT THE SURGERY TO TREAT THE FRACTURE OF THE RADIAL HEAD ON (B)(6) 2017. DURING THE PROCEDURE, RADIAL HEAD PLATE (RHP) WAS USED. AFTER 5 CORTICAL SCREWS WERE INSERTED TO THE HOLES IN THE HEAD OF THE PLATE, A CORTICAL SCREW WAS INSERTED TO THE SHAFT HOLE. WHILE THE SURGEON WAS INSERTING THE LOCKING SCREW TO THE SHAFT HOLE, THE SCREW BROKE AT THE NECK PART. THE PROCEDURE WAS COMPLETED BY SHIFTING THE PLATE POSITION AND USING ANOTHER SCREW. THE HEAD OF THE BROKEN SCREW WAS REMOVED, HOWEVER THE SHAFT OF THE SCREW REMAINED IN THE RADIAL SHAFT OF THE PATIENT. THE SURGEON LEFT THE BROKEN SCREW IN THE BONE SINCE THE SURGEON HAD TO MAKE A BIGGER HOLE IN ORDER TO REMOVE THE BROKEN PIECE. THE SURGEON COMMENTED THAT THE BROKEN SCREW WAS INSERTED FORCIBLY BY THE SCREWDRIVER WITHOUT TORQUE. NO DELAY IN SURGERY WAS REPORTED. CONCOMITANT DEVICES REPORTED: RHP PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), CORTICAL SCREW ((PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 5), SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.4MM TI LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725389 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM SCREW, FIXATION, BONE HWC SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR