BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE

    MDR report key: 2222312 · Received August 24, 2011

    Report

    Report Number
    2953769-2011-00103
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: FOLLOWED UP WITH COMPANY REPRESENTATIVE. PRODUCT ANALYSIS EVALUATION SUMMARY: ONE CURETTE DEVICE WAS RECEIVED FOR EVALUATION ON AUGUST 15, 2011. THE RETURNED CURETTE WAS VISUALLY EXAMINED FOR REPORTED FAILURE MODE PER COMPLAINT. THE FOLLOWING WAS OBSERVED ON THE RETURNED DEVICE DURING VISUAL INSPECTION: THERE WAS NO DAMAGE TO THE HANDLE, THE TIP WAS UNABLE TO BE ARTICULATED, THE TIP WAS SPLAYED, THE SCORE LINE WAS OBSERVED TO BE BROKEN. CONCLUSION: BASED ON THE VISUAL INSPECTION, THE HEAD OF THE ASSEMBLY WAS SPLAYED; THUS PREVENTED THE ASSEMBLY FROM BEING REMOVED FROM THE DOCKED CANNULA. THE REPORTED FAILURE MODE IN THE COMPLAINT IS CONSISTENT WITH THE INVESTIGATION RESULTS. PROBABLE ROOT CAUSE: BASED ON THE VISUAL INSPECTION OF THE TIP ASSEMBLY, THE TIP AND HEAD DID NOT BREAK AS REPORTED. THE HEAD SPLAYED AS A RESULT OF PRESSURE APPLIED BY THE TIP DURING BONE SCORING. THE HEAD EXPANDED BEYOND THE ID SPECIFICATION OF THE WORKING CANNULA, THEREFORE, PREVENTING THE CURETTE BEING REMOVED FROM THE WORKING SITE. THE SCORE LINE IS DESIGNED TO BREAK, SEPARATING THE METAL ASSEMBLY FROM THE CURETTE DEVICE, WHEN THE ROTATION OF THE HANDLE EXCEEDS THE DESIGN TORQUE SPECIFICATION. THE INTENT IS TO MINIMIZE BENDING OR BREAKING OF THE TIP. BASED ON THE OBSERVATION, THE SCORE LINE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CURETTE WAS USED TO SCORE SCLEROTIC BONE AS INDICATED AT T9. THE PHYSICIAN ACHIEVED A SATISFACTORY RESULT; HOWEVER, HE HEARD THE INSTRUMENT SNAP RIGHT BEFORE REMOVING THE CURETTE. THE CURETTE COULD NOT BE REMOVED THROUGH THE WORKING CANNULA. THE CANNULA AND CURETTE WERE REMOVED TOGETHER. A NEW CANNULA WAS INSERTED TO COMPLETE THE CASE. UPON REVIEWING THE DAMAGED CURETTE ON THE BACK TABLE, THE WEDGE TIP WAS SHOWN TO BE SLIGHTLY BENT, PREVENTING IT FROM RETRACTING THROUGH THE CANNULA. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT AND NO PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURETTE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SPINE LLC. 0004944433

    Patients

    Seq Age Sex Outcome Treatment
    1