BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4247753 · Received November 13, 2014

    Report

    Report Number
    2520274-2014-14695
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART NUMBERS 414.834S 4.5MM TI CORTEX SCREW SELF-TAPPING 34MM, 414.836S 4.5MM TI CORTEX SCREW SELF-TAPPING 36MM, 414.840S 4.5MM TI CORTEX SCREW SELF-TAPPING 40MM, 480.900S TI DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM (JDO - APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR), 412.123S 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/55MM-STER ( HSB - ROD, FIXATION, INTRAMEDULLARY), AND 412.152S LOCKING SCREWS WITH STARDRIVE SELF-DRILLING, SELF-TAPPING 12MM, WERE REPORTED BUT IT IS UNKNOWN WHICH SCREW WAS INVOLVED IN THE COMPLAINT. 414.834S: K112583, 414.836S: K112583, 414.840S: K112583, 480.900S: K953607, 412.123S: K103002 AND 412.152S: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 THE PRODUCTS WERE USED FOR FEMUR TROCHANTER COMMINUTED FRACTURE ON (B)(6) 2014. THE PATIENT HAD A PAIN THE NEXT DAY. ACCORDING TO X-RAY, THE PATIENT¿S BONE CRACKED AT THE DISTAL PART. THE PATIENT CONTINUED TO EXPERIENCE PAIN. ON (B)(6) 2014, IT WAS FOUND OUT BY X-RAY THAT THE FIXATION AT THE DISTAL PART WAS BROKEN. THE PATIENT WALKED UNDER WEIGHT-BEARING CONTROL AFTER THE SURGERY. THIS REPORT IS FOR AN UNKNOWN SCREW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734524 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention