BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    MDR report key: 4269175 · Received November 21, 2014

    Report

    Report Number
    3000270450-2014-10160
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE 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 NO PRODUCT WAS RECEIVED. MANUFACTURING LOCATION CORRESPONDING NON STERILE PART: SYNTHES USA HQ, INC. CORRESPONDING NON STERILE PART 04.210.120 LOT 7517942. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. VENDOR OF THE CORRESPONDING NON STERILE PART 04.210.120 LOT 7517942 IS SYNTHES USA HQ, INC. THUS, DHR REVIEW FOR UNSTERILE PART SHOULD BE PERFORMED AT THE US SITE. 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 THE SURGEON HAD DIFFICULTY IN INSERTING THE LOCKING SCREW SINCE THE TAPPING FUNCTION DID NOT WORK WELL. FINALLY, IT WAS FORCEFULLY COMPRESSED AND COULD BE INSERTED. IT SEEMS THAT CUTTING FLUTE OF VA LOCKING SCREW IS BIGGER AND NOT AS SHARP COMPARED TO STANDARD LOCKING SCREW'S. THEREFORE THE OPERATION WAS EXTENDED 15 MINUTES. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756900 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE,FIXATION,BONE HRS SYNTHES SELZACH 8775443

    Patients

    Seq Age Sex Outcome Treatment
    1