BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER AXSOS T20 5.0MM LOCKING SET

    MDR report key: 3864976 · Received June 11, 2014

    Report

    Report Number
    0008031020-2014-00273
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE SCREWDRIVER TIP BROKEN FOR SCREWDRIVER AXSOS T20 5.0MM LOCKING SET COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT WAS ATTRIBUTED TO A USER RELATED ISSUE. "DETAILS OF INCIDENT / NATURE OF DEVICE DEFECT DURING THE TRAUMA LIST IN THEATRE 6, THE SURGEON WAS PLATING A RIGHT FEMUR AND WHILE POSITIONING A LOCKING SCREW INTO THE PLATE THE TIP IF THE SCREWDRIVER BROKE OFF IN THE SCREW. THE SURGEON WAS UNABLE TO GET THE SCREW OUT AND UNABLE TO REMOVE THE TIP OF THE SCREWDRIVER. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): THE TIP OF THE AXSOS 5MM SCREWDRIVER REMAINS IN THE SCREW, FIXED IN THE AXSOS PLATE IN THE RIGHT FEMUR OF THE PATIENT." (PI 536707 MHRA ADVERSE INCIDENT REPORT) THE SURGEON USED A LOCKING SCREW: NOTE: "ADDITIONAL TIPS - 5. DO NOT USE POWER FOR FINAL INSERTION OF LOCKING SCREWS. IT IS IMPERATIVE TO ENGAGE THE SCREW HEAD INTO THE PLATE USING THE TORQUE LIMITING ATTACHMENT. ENSURE THAT THE SCREWDRIVER TIP IS FULLY SEATED IN THE SCREW HEAD, BUT DO NOT APPLY AXIAL FORCE DURING FINAL TIGHTENING. IF THE SCREW STOPS SHORT OF FINAL POSITION, BACK UP A FEW TURNS AND ADVANCE THE SCREW AGAIN (WITH TORQUE LIMITER ON)." (982301 REV 3 AXSOS DISTAL LATERAL FEMUR OPTECH, 982301 REV 3) [ORIGINAL STATEMENT] "IN THE EXTREME EVENT OF BROKEN OR STRIPPED SCREWS, THE STRYKER IMPLANT EXTRACTION SET (LITERATURE NUMBER LIES-OT) INCLUDES A VARIETY OF BROKEN SCREW REMOVAL INSTRUMENTS." (982301 REV 3 AXSOS DISTAL LATERAL FEMUR OPTECH, 982301 REV 3) [ORIGINAL STATEMENT] " ¿ ALWAYS TREAT THE INSTRUMENT CAREFULLY TO AVOID SURFACE DAMAGE OR ALTERATIONS TO THE INSTRUMENT GEOMETRY. [...] ¿ IN THE COURSE OF THE OPERATION, REPEATEDLY CHECK THAT THE CONNECTIONS REQUIRED FOR PRECISE POSITIONING BETWEEN THE IMPLANT AND INSTRUMENTS, OR BETWEEN THE INSTRUMENTS THEMSELVES, ARE SECURE." (V15011 REV K 01-2014 INSTRUMENTS IFU) NC/CAPA HAVE BEEN FOUND FOR THIS REF# IN AMENDMENT SEL11-232 (DRAWING INDEX J) AN OPTIMIZATION OF THE FOLLOWING DRAWINGS WAS REALIZED: -TORX SHORTEN LENGTH OF SCREWDRIVER 702748 AND 702754 FROM 3.5MM TO 1.9MM +/- 0.2 +/- 0.2 DUE TO THE CHANGE: -BY THE REDUCTION OF THE BLADE PART IS TRANSFERRED FROM THE TORQUE IN THE TRANSITION RADIUS R4 WHICH INCREASES THE STRENGTH OF TORX. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    THE SALES REP,REPORTED ON BEHALF OF THE CUSTOMER, THAT DURING USE THE TIP OF THE AXOS SCREWDRIVER ALLEGEDLY BROKE OFF. THE SALES REP HAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER SCREWDRIVER, HOWEVER THE TIP OF THE ORIGINAL SCREWDRIVER WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT.

    Description of Event or Problem · 1

    THE SALES REP,REPORTED ON BEHALF OF THE CUSTOMER, THAT DURING USE THE TIP OF THE AXOS SCREWDRIVER ALLEGEDLY BROKE OFF. THE SALES REP HAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER SCREWDRIVER, HOWEVER THE TIP OF THE ORIGINAL SCREWDRIVER WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345618 SCREWDRIVER AXSOS T20 5.0MM LOCKING SET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH R00906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other