BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL

    MDR report key: 5010675 · Received August 18, 2015

    Report

    Report Number
    2520274-2015-15258
    Event Type
    Injury
    Date Received
    August 18, 2015
    Report Date
    March 18, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART 413.336, LOT 8493907: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 36MM; PRODUCT CODE: KTT APPLIANCE, FIXATION, NAIL; 510K: K000682. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 21JUNE2013. PART 413.344, LOT 8132797: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 44MM; PRODUCT CODE: KTT APPLIANCE, FIXATION, NAIL; 510K: K023941. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 26OCTOBER2012. PART 413.342, LOT 8061646: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 42MM; PRODUCT CODE: KTT APPLIANCE, FIXATION, NAIL; 510K: K000682. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 10SEPTEMBER2012. PART 413.332, LOT 8400758: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 32MM; PRODUCT CODE: KTT APPLIANCE, FIXATION, NAIL; 510K: K000682. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 18APRIL2013. PART 413.334, LOT 2806309: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 34MM; PRODUCT CODE: KTT APPLIANCE, FIXATION, NAIL; 510K: K000682. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 10NOVEMBER2011. PART 414.836, LOT 8322532: 4.5MM TI CORTEX SCREW SELF-TAPPING 36MM; PRODUCT CODE: HWC SCREW, FIXATION, BONE; 510K: K112583. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 27FEBRUARY2013. (B)(6) (B)(4) A REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL POTENTIALLY INVOLVED LOTS WAS COMPLETED: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING EVALUATION WAS COMPLETED: THE RETURNED SCREWS WERE ALL RECEIVED INTACT. 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 PLATE THAT HAD BEEN PLACED ON THE FEMUR BROKE AFTER A PSEUDOARTHROSIS. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545993 APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention