BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM CORTEX SCREW SELF-TAPPING 20MM

    MDR report key: 6676862 · Received June 29, 2017

    Report

    Report Number
    1719045-2017-10611
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    June 1, 2017
    Report Date
    June 1, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT ID (B)(6). ADDITIONAL DEVICE PRODUCT CODE: KTW. UDI# (B)(4). EVENT OCCURRED INTRAOPERATIVE. DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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 ON (B)(6) 2017, PATIENT UNDERWENT SURGERY FOR A LEFT OPEN DISTAL RADIUS FRACTURE. DURING THE SURGERY, A 2.7 CORTEX SCREW FROM A SMALL FRAGMENT SET BROKE. THE SCREW SHAFT WAS LEFT IN THE BONE AND THE SCREW HEAD WAS REMOVED. IT WAS THE LAST SCREW PLACED WHEN IT BROKE. NO ADDITIONAL SCREWS WERE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THERE WAS DELAY IN SURGERY TIME. THE PATIENT OUTCOME WAS REPORTED AS BEING FINE. CONCOMITANT DEVICES REPORTED: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/5H SHAFT/LEFT (PART # 02.111.751, LOT # UNKNOWN, QUANTITY 1), SCREW DRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458398 2.7MM CORTEX SCREW SELF-TAPPING 20MM SCREW,FIXATION,BONE HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR