BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI LCP® PLATE 7 HOLES 98MM

    MDR report key: 3863665 · Received June 10, 2014

    Report

    Report Number
    2520274-2014-11717
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    PK000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. DEVICE COULD NOT BE EXPLANTED; IT REMAINS IN THE PATIENT. 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 LOCKING COMPRESSION PLATES AND SCREWS WERE IMPLANTED IN A PATIENT WITH A RADIUS AND ULNAR SHAFT FRACTURE ON (B)(6) 2012. THERE WAS A REMOVAL OPERATION OF THE IMPLANTS ON (B)(6) 2014. THE PLATE AND SCREWS FOR THE ULNAR WERE SUCCESSFULLY REMOVED. BUT FOR THE RADIUS, THREE SCREWS HAD WORN OUT AND COULD NOT BE REMOVED. THE HIGH SPEED STERILE DRILL BIT WAS USED, BUT THE SCREWS STILL COULD NOT BE REMOVED. THE PLATE AND SCREWS WERE LEFT IN THE PATIENT BODY AND THE OPERATION WAS FINISHED. THE OPERATION WAS EXTENDED FOR TWENTY MINUTES DUE TO THE INCIDENT. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337589 3.5MM TI LCP® PLATE 7 HOLES 98MM APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR