BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE(TM) SCREWDRIVER T15

    MDR report key: 3053011 · Received April 11, 2013

    Report

    Report Number
    2530088-2013-10394
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    May 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A PRODUCT DEVELOPMENT EVALUATION AND THE TIP OF THE SCREWDRIVER WAS BROKEN OFF. THE BREAK WAS OBLIQUE AND APPROXIMATELY 11 MM FROM THE TIP TRANSITION TO THE SHAFT OUTER DIAMETER ON ONE SIDE, AND 7 MM ON THE OPPOSITE SIDE. THE FRACTURE SURFACE WAS HOMOGENOUS AND THERE WAS NO INDICATION OF MATERIAL IRREGULARITIES. THE RETURNED DEVICE WAS MANUFACTURED IN AUGUST 2002 AND IS OVER 9 YEARS OLD. AS NOTED IN PREVIOUS EVALUATIONS, THESE DEVICES ARE USED TO TIGHTEN AND LOOSEN SCREWS WITH A T15 STARDRIVE RECESS. THE RECOMMENDED TIGHTENING TORQUE IS 1.5NM, WHICH CAUSES NO DEFORMATION OR STRIPPING. REMOVAL CAN PRESENT ISSUES, HOWEVER, AS OVER TIME THE COMBINATION OF DEBRIS IN THE RECESS, BONY OVERGROWTH AND SCREW BINDING CAN MAKE REMOVAL VERY CHALLENGING. THERE ARE MANY FACTORS THAT INFLUENCE THE ABILITY TO REMOVE SCREWS WITHOUT STRIPPING THE SCREWDRIVER OR RECESS. THESE FACTORS INCLUDE PROPER ENGAGEMENT OF THE SCREWDRIVER IN THE RECESS, ORIENTATION OF THE SCREWDRIVER, APPLIED TORQUE, AND ROTATIONAL SPEED OF THE DRIVER. THE DESIGN IS ADEQUATE FOR THE INTENDED USE AND THE COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION ANKLE, PROCEDURE, AS THE SURGEON WAS INSERTING THE SCREW, THE TIP OF THE SCREWDRIVER SHEARED OFF. A BROKEN FRAGMENT WAS RETRIEVED AND DISCARDED. THE SURGEON USED ANOTHER SCREWDRIVER SHAFT TO COMPLETE PROCEDURE WITH NO FURTHER PROBLEMS AND NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155669 STARDRIVE(TM) SCREWDRIVER T15 HXX SYNTHES BRANDYWINE 4455407

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR