BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT

    MDR report key: 2896763 · Received December 28, 2012

    Report

    Report Number
    9617544-2012-00612
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - MFG RECORD REVIEW, COMPLAINT HISTORY ANALYSIS, LABELING REVIEW AND RISK ASSESSMENT. RESULT - A THOROUGH INVESTIGATION COULD NOT BE PERFORMED DUE TO THE UNAVAILABILITY OF THE IMPLICATED DEVICE. MFG RECORD REVIEW: NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED DURING THE MFG. COMPLAINT HISTORY ANALYSIS: (B)(4) PREVIOUS RECORDS HAVE BEEN RECEIVED. INVESTIGATIONS INTO PAST COMPLAINTS CONCLUDED THAT THE FAILURES WERE THE RESULT OF USER-ERROR. THE SURGICAL TECHNIQUE ALSO STATES THAT "THE SCREW EXTRACTOR 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. RISK ASSESSMENT: THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THE REPORTED EVENT. THE INSTRUMENT TIP IS MADE FROM BIOCOMPATIBLE MATERIAL TO MITIGATE THE RISK OF IT REMAINING IN A POTENTIAL PT. IN THE ABSENCE OF THE REFLEX-HYBRID SCREW EXTRACTOR, THE REFLEX-HYBRID REVISION DRIVER CAN BE USED TO EXTRACT SCREWS. CONCLUSION: IT BELIEVED TO BE THE RESULT OF USER-ERROR. THE SURGICAL TECHNIQUE STATES THAT CANTILEVERING THE INSTRUMENT MAY DAMAGE THE TIP OF THE INSTRUMENT.

    Description of Event or Problem · 1

    (B)(6), OPERATING ROOM MGR AT THE HOSP, REPORTED THAT "DURING A SURGERY, THE TIP OF THE SCREWDRIVER FRACTURED INTO THE SCREW, WHICH REMAINS INTO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 110232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK