BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 55MM

    MDR report key: 3911292 · Received July 2, 2014

    Report

    Report Number
    2520274-2014-12370
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SYNTHES USA
    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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE 314.453, LOT NUMBER ILLEGIBLE FROM WEAR, T8 STARDRIVER SHAFT WAS RECEIVED INTACT WITH VISIBLE SIGNS OF WEAR AT THE STARDRIVE TIP AND PROXIMAL ENGAGEMENT TAB. THE DEVICE IS INTENDED FOR USE IN THE ENGAGEMENT AND LOOSENING OF T8 SCREWS THE VARIABLE ANGLE-LOCKING COMPRESSION PLATE SYSTEMS FOR THE ELBOW, DISTAL RADIUS, ANKLE, AND CLAVICLE TO INSERT THE LOCKING SCREWS AND BUTTRESS PINS AS PROVIDED IN TECHNIQUE GUIDES. THE RELEVANT PRODUCT DRAWING AND ENGINEERING STANDARDS WERE REVIEWED DURING THE INVESTIGATION. THE STARDRIVE SCREWDRIVER SHAFT IS A HEXALOBULAR DRIVE FEATURE DESIGNED TO HAVE A SELF-RETAINING EFFECT. THE SCREWDRIVER SHAFT IS MADE FROM HARDENED AND TEMPERED 1.4028 SS AND IS ADEQUATE FOR THE INSTRUMENT¿S INTENDED USE. THE HARDENING AND TEMPERING PROCESS INCREASES THE MATERIALS TOUGHNESS ALLOWING THE INSTRUMENT TO PLASTICALLY DEFORM BEFORE FRACTURING AND THEREFORE REDUCING THE RISK THE INSTRUMENT WILL BREAK. BASED ON THE ENGINEERING STANDARDS FOR THE T8 STARDRIVE SCREWDRIVER BLADE AND THE ENGINEERING STANDARDS FOR THE T8 STARDRIVE RECESS IN SCREWS, THE SCREWDRIVER IS DIMENSIONED AND TOLERANCED APPROPRIATELY ALLOWING ONLY FOR PURPOSELY DESIGNED INTERFERENCE WHICH GIVES THE SCREWDRIVER ITS RETAINING FEATURES. THE MATERIAL AND DIMENSIONS ARE ADEQUATE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE COMPLAINT CONDITION MAY HAVE OCCURRED DUE TO INCORRECT ALIGNMENT AND OVER-TORQUING OR POWERED DRIVING CAUSING THE STARDRIVE TIP TO BEND. THIS WOULD CREATE INTERFERENCE BETWEEN THE INNER RADIUS OF THE SCREWDRIVER AND THE INNER RADIUS OF THE RECESS ON THE SCREW AS THE CONDITION OF THE STARDRIVE TIP SUGGESTS. IT IS PROBABLE THAT THE METHOD OF OFF ANGLE AND/OR OVER TORQUING HAS LED TO THIS CONFIRMED COMPLAINT AND IS NOT THE RESULT OF A DESIGN DEFICIENCY. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED SEVERAL INSTRUMENTS WERE FOUND DAMAGED DURING CLEANING AND STERILE PROCESSING. THREE STARDRIVE SCREWDRIVERS, HAVE ALL BECOME WORN AND NO LONGER ARE CAPABLE OF PICKING UP SCREWS. ONE MESH PLATE CUTTER IS BROKEN INTO TWO PARTS AT ONE OF THE END PIECES. ONE HEXAGONAL SCREWDRIVER IS BROKEN AND MISSING THE TIP. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385668 STARDRIVE SCREWDRIVER SHAFT T8 55MM SCREWDRIVERS HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1