BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR

    MDR report key: 2943389 · Received February 5, 2013

    Report

    Report Number
    0009617544-2013-00010
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY AND RISK ASSESSMENT ANALYSIS. RESULTS: VISUAL INSPECTION: THE RETURNED INSTRUMENT WAS VISUALLY INSPECTED AND THE DISTAL THREADED TIP WAS CONFIRMED TO BE BROKEN. THE BROKEN FRAGMENT WAS NOT RETURNED. DEVICE HISTORY REVIEW: THE DHR FROM BATCH 109528 WAS REVIEWED BUT NO RELEVANT DEVIATIONS WERE REPORTED. (B)(4). RISK ANALYSIS: THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SIGNIFICANT DELAYS IN SURGERY AS A RESULT OF THE REPORTED EVENT. THE SEVERITY THRESHOLDS HAVE NOT BEEN BREACHED. THE REFLEX-HYBRID REVISION DRIVER DRAW ROD TIP IS NOW MADE FROM BIOCOMPATIBLE MATERIAL TO MITIGATE THE RISK OF IT REMAINING IN A POTENTIAL PATIENT. CONCLUSION: THE RETURNED INSTRUMENT WAS VISUALLY INSPECTED AND THE DISTAL THREADED TIP WAS CONFIRMED TO BE BROKEN. NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED DURING THE MANUFACTURING OF BATCH 109528. THE INSTRUMENT FAILURE IS BELIEVED TO BE THE RESULT OF USER-ERROR. THE SURGICAL TECHNIQUE STATES THAT "WHILE THE REVISION DRIVER IS ATTACHED TO THE SCREW, PIVOTING OR ANGULATION OF THE INSTRUMENT MUST BE AVOIDED AS THIS CAN CAUSE BENDING OR BREAKING OF THE INNER SHAFT ". THE SURGICAL TECHNIQUE ALSO STATES THAT "THE REVISION DRIVER MUST BE AXIALLY ALIGNED WITH THE SCREW TRAJECTORY AND FULLY SEATED IN THE SCREW HEAD BEFORE INSERTING OR TIGHTENING THE INNER SHAFT ". EXCESSIVE TIGHTENING COULD ALSO RESULT IN THE DEFORMATION OF THE INSTRUMENT DISTAL TIP. IT HAS BEEN ACKNOWLEDGED THAT BREAKAGES OF THE INSTRUMENT DISTAL TIP WILL OCCUR DUE TO THE NATURE OF REVISION SURGERY AS WELL AS THE SMALL DRAW ROD DIAMETER REQUIRED TO INTERFACE WITH A SCREW IN THE CERVICAL SPINE. THE REFLEX-HYBRID REVISION DRIVER DRAW ROD TIP IS NOW MADE FROM BIOCOMPATIBLE MATERIAL TO MITIGATE THE RISK OF IT REMAINING IN A POTENTIAL PATIENT. THE RATE OF FAILURE AND RELATED SEVERITIES ARE WITHIN THRESHOLDS LEVELS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED, "TIP OF INSERTER BROKE OFF INTO THE SCREW DURING HARDWARE REMOVAL."

    Description of Event or Problem · 1

    AS REPORTED, "TIP OF INSERTER BROKE OFF INTO THE SCREW DURING HARDWARE REMOAVAL"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48331 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR INSTRUMENT LXH STRYKER SPINE-FRANCE 109528

    Patients

    Seq Age Sex Outcome Treatment
    1