BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED ANGLE GUIDE OMEGA 135°

    MDR report key: 3864981 · Received June 11, 2014

    Report

    Report Number
    0008031020-2014-00278
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    March 28, 2012
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE FIXED ANGLE GUIDE DOES NOT GUIDE 135° COULD NOT BE CONFIRMED. THE INSPECTION OF THE DEVICE SHOWED NO DEVIATIONS. BASED ON THE INVESTIGATION, THE ROOT CAUSE OF THE WRONG ANGLE WAS ATTRIBUTED TO A USER RELATED ISSUE. AS DESCRIBED IN THE OPERATIVE TECHNIQUE OMEGA3 SYSTEM COMPRESSION HIP SCREW (REF# 982306) BE SURE TO HOLD THE ANGLE GUIDE FIRMLY ON THE FEMORAL SHAFT. ANY TILTING OR TWISTING CAN AFFECT ACHIEVING THE DESIRED ANGLE. FURTHERMORE THE OPERATIVE TECHNIQUE STATES THAT THE GUIDE PIN SHOULD BE INSERTED UNDER IMAGE INTENSIFICATION: ¿WHILE HOLDING THE APPROPRIATE ANGLE GUIDE FIRMLY ON THE FEMORAL SHAFT, THE 2.8MM GUIDE PIN IS INSERTED IN THE HOLE OF THE ANGLE GUIDE AND ADVANCED INTO THE FEMORAL HEAD UNDER IMAGE INTENSIFICATION UNTIL IT REACHES THE SUBCHONDRAL BONE IN THE CENTER OF THE FEMORAL HEAD IN BOTH FRONTAL AND LATERAL VIEWS (FIG. 11 & 12). IF THE GUIDE PIN IS NOT POSITIONED CORRECTLY, AN ADDITIONAL PIN CAN BE INSERTED 5MM ABOVE OR BELOW THE CENTRAL POSITION IN THE FRONTAL PLANE, AND 5MM ANTERIORLY OR POSTERIORLY TO THE CENTRAL POSITION IN THE LATERAL PLANE, WITHOUT REMOVING THE FIRST GUIDE PIN (FIG. 13 & 14).¿ [ORIGINAL STATEMENT] A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SALES REP, REPORTED THAT DURING AN OMEGA3 SURGERY THE SURGEON EXPERIENCED MISDRILLING IN NECK OF FEMUR AND QUESTIONED THE FIXED ANGLE GUIDE INSTRUMENT. NO REPLACEMENT DEVICE USED.

    Description of Event or Problem · 1

    THE SALES REP, REPORTED THAT DURING AN OMEGA3 SURGERY THE SURGEON EXPERIENCED MISDRILLING IN NECK OF FEMUR AND QUESTIONED THE FIXED ANGLE GUIDE INSTRUMENT. NO REPLACEMENT DEVICE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345706 FIXED ANGLE GUIDE OMEGA 135° ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH W37498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other