BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR

    MDR report key: 3771475 · Received April 24, 2014

    Report

    Report Number
    0009617544-2014-00175
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; DEVICE HISTORY REVIEW; RESULTS: NO MANUFACTURING ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED. THIS IS THE FIRST REPORTED OCCURRENCE ASSOCIATED WITH THIS MANUFACTURING LOT NUMBER. THE INSTRUMENT FRACTURE MAY A RESULT OF OVER TIGHTENING. EXCESSIVE TIGHTENING COULD ALSO RESULT IN THE DEFORMATION OF THE INSTRUMENT DISTAL TIP. THE ROOT CAUSE IS NOT DETERMINED, MULTI-FACTORIAL. CONCLUSION: THE LIKELY MODE WAS TORSIONAL OVERLOAD BUT THE PRODUCT WAS NOT RETURNED FOR VISUAL EXAMINATION.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE REFLEX HYBRID REVISION DRIVER SCREW EXTRACTOR WAS NOT RETURNED, THEREFORE IT CANNOT BE CONFIRMED THE DISTAL THREADED TIP BROKEN OFF DURING DEMONSTRATION, EXCEPT FOR THE SALES REP REPORT. NO MANUFACTURING ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED. THE INSTRUMENT FRACTURE MAY A RESULT OF OVER TIGHTENING. EXCESSIVE TIGHTENING COULD ALSO RESULT IN THE DEFORMATION OF THE INSTRUMENT DISTAL TIP. CONCLUSION: THE LIKELY MODE WAS TORSIONAL OVERLOAD BUT THE PRODUCT WAS NOT RETURNED FOR VISUAL EXAMINATION, THEREFORE, THE EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED AND IS LIKELY MULTIFACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF THE REVISION DRIVER DRAW ROD WAS BROKEN WHEN DOING WORKSHOP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF THE REVISION DRIVER DRAW ROD WAS BROKEN WHEN DOING WORKSHOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248962 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR INSTRUMENT- SCREW EXTRACTOR DRIVER LXH STRYKER SPINE-FRANCE 119316

    Patients

    Seq Age Sex Outcome Treatment
    1