BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T4/66MM

    MDR report key: 3820003 · Received May 20, 2014

    Report

    Report Number
    1719045-2014-10209
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: TWO PARTS OF THE STARDRIVE SCREWDRIVER SHAFT, T4, 66MM (PART NUMBER 03.114.010, LOT NUMBERS 6567238 AND 7413800) WAS RETURNED WITHOUT THE HOLDING SLEEVE DUE TO TWISTING/BENDING. THE PART WAS OBSERVED TO HAVE DAMAGE TO THE TIP. THE TIP HAS BEEN TWISTED AXIALLY SLIGHTLY AGAINST THE DIRECTION OF TIGHTENING. THE RELEVANT DRAWING WAS REVIEWED FOR CONFORMANCE. THE DRAWINGS CONFIRM THAT THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. THE BLADES WERE CONFIRMED TO BE FABRICATED FROM 465 SS PER ASTM F899/A564. THE DIMENSIONS, MATERIALS, AND FINISHING PROCESSES ARE APPROPRIATE FOR THE DESIGN OF A ROBUST STARDRIVE SCREWDRIVER AT THE TIME OF MANUFACTURE. THE PRELIMINARY ROOT CAUSE WAS DETERMINED TO BE THAT THE TOOL FAILURE WAS BY DESIGN TO PROTECT THE PATIENT. THE TOOL FUNCTIONED EXACTLY AS INTENDED, AND PROTECTED THE PATIENTS WHEN EXCESSIVE TORQUE WAS APPLIED. IF CORRECTIVE AND/OR PREVENTATIVE ACTION WERE TAKEN TO STRENGTHEN THE SCREWDRIVER, AND THUS PREVENT SCREWDRIVER FAILURE, WITHOUT FURTHER EVALUATION OF TOOL DESIGN AND FIELD USE, THIS MAY HAVE AN ADVERSE IMPACT ON PATIENT SAFETY DURING TOOL USE. 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

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION OF A PROXIMAL PHALANX WAS PERFORMED ON; (B)(6) 2014. TWO SCREWDRIVERS WERE BENT AND STRIPPED. WHEN THE SURGEON WAS INSERTING THE SCREWS THROUGH THE PLATE THEY WERE UNABLE TO TIGHTEN THEM. THE SURGEON THEN NOTICED THAT THE FIRST SCREWDRIVER SHAFT WAS BENT AND STRIPPED. THERE WERE ALSO REPORTS OF THE SAME ISSUE WITH THE SECOND SHAFT. THERE WAS A THIRD SHAFT THAT WAS USED WHICH FUNCTIONED PROPERLY. THERE WERE NO REPORTS OF FRAGMENTS OR BREAKAGE OF THE SHAFTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY MINUTE DELAY AND THERE WAS NO PATIENT HARM. THIS REPORT IS FOR 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300259 STARDRIVE SCREWDRIVER SHAFT T4/66MM SCREWDRIVERS HXX SYNTHES MONUMENT 6567238

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR