BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 3831653 · Received May 26, 2014

    Report

    Report Number
    2520274-2014-11608
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZL
    PMA / PMN Number
    PK083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE SCREW IS BEHEADED THE TWO SCREWS ARE BROKEN OFF AS COMPLAINED. THE LISTED DRILL BIT WAS NOT RETURNED AND THE EXACT LOT NUMBER IS UNKNOWN THEREFORE NO INVESTIGATION COULD BE PERFORMED. THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF MECHANICAL OVERLOADING DURING REPETITIVE BENDING RESULTED IN THE BREAKAGE. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY FOR A MALAR FRACTURE A 6MM SCREW BROKE, AN 8MM SCREW BROKE AND A DRILL BIT BROKE. THERE WAS NO REPORT OF INJURY OR PROLONGED SURGICAL TIME. THE BROKEN DEVICES WERE REPLACED WITH OTHERS TO COMPLETE THE PROCEDURE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309927 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM SCREW, FIXATION, INTRAOSSEOUS DZL SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR