BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L22 TI

    MDR report key: 3706140 · Received March 27, 2014

    Report

    Report Number
    3009450884-2014-10007
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 10, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    PK131186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODE: HWC. A MANUFACTURING EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINED SCREW SHOWS THAT THE SCREW IS BROKEN ON THE POSITION BY THE LAST PITCH OF THE THREAD LOCATED BY THE HEAD OF THE SCREW. IT IS LIKELY THAT TOO MUCH APPLIED MECHANICAL FORCE WELL BEYOND ITS CALCULATED DESIGN DURING USE CAUSED THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 LCP-CHP (LOCKING COMPRESSION PLATE- CLAVICLE HOOK PLATE) WAS USED FOR A DISTAL END CLAVICLE FRACTURE CASE. AFTER THE REDUCTION, A PLATE WAS PLACED AND THEN A CORTEX SCREW WAS INSERTED AT THE PROXIMAL SIDE. THE CORTEX SCREW WAS INSERTED INTO THE PROXIMAL THIRD HOLE. AFTER THAT, TWO CORTEX SCREWS WERE INSERTED IN THE PROXIMAL FIRST AND SECOND HOLES, RESPECTIVELY. FINALLY, A LOCKING SCREW WAS INSERTED IN THE MOST DISTAL HOLE. WHEN FURTHER TIGHTENING WAS APPLIED TO THE THREE PROXIMAL SCREWS, THE SCREW IN QUESTION BROKE JUST BELOW ITS HEAD. THE BROKEN PART WAS LEFT IN THE PATIENT AND THE OPERATION WAS COMPLETED. THE BROKEN PART WILL BE EXTRACTED AT REMOVAL OPERATION. A FIVE MINUTE SURGICAL DELAY WAS REPORTED. THIS REPORT IS FOR 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183611 CORTSCR Ø3.5 L22 TI PLATE, FIXATION, BONE HRS SYNTHES GRENCHEN 8182645

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR