BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED STARDRIVE SCREWDRIVER SHAFT FOR 3.0MM HCS T8

    MDR report key: 4118739 · Received September 25, 2014

    Report

    Report Number
    9612488-2014-10403
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THIS INSTRUMENT IS USED FOR INSERTING AND EXTRACTING HEADLESS COMPRESSION SCREWS IN PROCEDURES FOR THE FIXATION OF SMALL BONES AND SMALL BONE FRAGMENTS. THIS INFORMATION IS PROVIDED PER THE 2.4MM AND 3.0MM HEADLESS COMPRESSION SCREWS TECHNIQUE GUIDE. THE RETURNED SCREWDRIVER SHAFT, LOT 2213646, WAS MANUFACTURED SEPTEMBER, 2006. IT WAS RECEIVED WITH A PORTION OF THE DISTAL TIP BROKEN OFF. IT IS BROKEN SUCH THAT A 3MM LENGTH IS MISSING FROM THREE QUARTERS OF THE DISTAL TIP AND WAS NOT RETURNED. THE LAST QUARTER OF THE DISTAL TIP IS INTACT. THE BALANCE OF THE TOOL IS IN GOOD CONDITION AND THE ETCHINGS AND MARKINGS ARE INTACT. THE BREAK IS CONSISTENT WITH THE RESULT FROM TORQUE IN EXCESS OF THAT REQUIRED FOR ITS INTENDED USE. PER THE TECHNIQUE GUIDE THE SCREW IS TO BE INSERTED AND EXTRACTED BY HAND. THE COMPLAINT CONDITION CANNOT BE REPLICATED BECAUSE THE SCREWDRIVER SHAFT IS ALREADY BROKEN BUT THE COMPLAINT CONDITION IS CONFIRMED AND LIKELY THE RESULT OF THE METHOD OF USE. A REVIEW OF THE CURRENT EDITION OF THE DESIGN DRAWING WAS PERFORMED. THE 1.18MM CANNULATION IS NECESSARY TO PROVIDE PRECISE SCREW PLACEMENT VIA A 1.1MM GUIDE WIRE AND THE T8 STARDRIVE GEOMETRY AT THE TIP IS NECESSARY TO ENGAGE THE T8 STARDRIVE RECESS IN 2.4MM AND 3.0MM SELF-DRILLING, SELF-TAPPING CANNULATED HEADLESS COMPRESSION SCREWS. TO ACCOUNT FOR THIS, THE SCREWDRIVER SHAFT IS MANUFACTURED FROM HARDENED AND TEMPERED X15TN STAINLESS STEEL, A COMMONLY USED HIGH STRENGTH, CORROSION RESISTANT MATERIAL COMMON IN INSTRUMENT APPLICATIONS. THUS, THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE AND THE COMPLAINT CONDITION IS NOT THE RESULT OF A DESIGN DEFICIENCY. IN CONCLUSION, THE COMPLAINT CONDITION IS CONFIRMED AND LIKELY THE RESULT OF TORQUE IN EXCESS OF THAT REQUIRED FOR ITS INTENDED USE. THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE AND THE RISK ANALYSIS ADEQUATELY ADDRESSES THE HARM OF THIS COMPLAINT CONDITION. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE END OF A SCREWDRIVER BROKE INTRA-OPERATIVELY, THE EVENT OCCURRED OUTSIDE THE PATIENT FIELD. A FIVE MINUTE SURGICAL DELAY WAS REPORTED TO FIND ANOTHER SCREWDRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597602 CANNULATED STARDRIVE SCREWDRIVER SHAFT FOR 3.0MM HCS T8 SCREWDRIVER HXX SYNTHES BETTLACH 2213646

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR