BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4251515 · Received November 14, 2014

    Report

    Report Number
    2520274-2014-14754
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR TWO UNKNOWN MATRIX RIB SCREWS/UNKNOWN LOTS. PART NUMBERS: TWO 04.501.022 AND FOUR 04.501.024 WERE PROVIDED, BUT IT IS UNKNOWN WHICH SCREWS WERE THE ONES THAT DISLODGED. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE USE OF MATRIXRIB SCREWS IN TITANIUM STERNAL FIXATION SYSTEM (TSFS) PLATES IS OFF-LABEL USE OF THESE SYSTEMS. THE MIXTURE OF DIFFERENT PRODUCTS IS NOT APPROVED BY THE MANUFACTURER AND CAN NOT BE COMMENTED ON. THE FIRST ON-LABEL USE (AS DESCRIBED IN THE COMPLAINT) OF THE TSFS PLATE (460.036) WITH TSFS SELF DRILLING SCREWS OF DIFFERENT LENGTHS, CAN NOT BE EVALUATED SINCE MATRIXCRIB SCREWS HAD BEEN INSERTED INTO THE SAME LOCATION AND MAY HAVE ALTERED THE SITUATION.THEREFORE, PRODUCT DEVELOPMENT CAN NOT INVESTIGATE THIS COMPLAINT AND CLOSES THIS INVESTIGATION AS IN-VALID. 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 SURGEON HAD AN ISSUE DURING SURGERY FIXING THE PLATE WITH THE SELF-DRILLING SCREWS IN THE KIT. THE ONLY OTHER SCREWS AVAILABLE WERE MATRIX RIB SCREWS. THE PLATE WAS FIXED AND PATIENT WAS CLOSED. THE PATIENT RETURNED TO SURGERY DUE TO SCREWS DISLODGING FROM PLATE. THIS REPORT IS FOR TWO UNKNOWN MATRIX RIB SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736694 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention