BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX LONG

    MDR report key: 4242438 · Received November 11, 2014

    Report

    Report Number
    1719045-2014-10575
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REVIEW OF THE DHRS FOR P/N 03.632.072, LOT 6755412, SHOWED NO NONCONFORMANCES GENERATED DURING PRODUCTION. THE REWORK ADDED A MARK TO THE BAR STOCK TO INDICATE ALLOY TYPE AND LOT NUMBER TO ENSURE USE OF CORRECT ALLOY FOR PRODUCT. THE BARS PASSED INSPECTION USING XRFA ANALYSIS TO CONFIRM ALLOY TYPE. THIS REWORK IS NOT RELEVANT TO THE COMPLAINT CONDITION AS THE BAR MARK IS ON THE END OF THE BAR STOCK. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION OF THE SCREWDRIVER HAS SHOWN THAT THE STARDRIVE-TIP IS BROKEN OFF. THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE COMPLAINT DESCRIPTION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THAT A MECHANICAL OVERLOAD DURING THE LOOSENING OF A POSSIBLY BLOCKED LOCKING CAP CAUSED THIS BREAKAGE. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HEAD OF THE SCREWDRIVER IS BROKEN. IT HAPPENED DURING SURGERY NO PATIENT HARM. THIS REPORT IS 1 OF 1 FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727828 T25 STARDRIVE SHAFT F/MATRIX LONG SCREWDRIVERS HXX SYNTHES MONUMENT 6755412

    Patients

    Seq Age Sex Outcome Treatment
    1