BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW BLADE LINVATEC®/HALL® POWERPRO®

    MDR report key: 5820281 · Received July 25, 2016

    Report

    Report Number
    0002950261-2016-00008
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    June 27, 2016
    Report Date
    September 12, 2016
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS MANUFACTURED IN THE (B)(4). THE INFORMATION FOR THIS RESPONSE WAS PROVIDED BY THE QUALITY DEPARTMENT AT THE (B)(4). THE 19105119LG1 IS THE CATALOGUE NUMBER FOR PURCHASING THE STABLE ZIM GTS OSC LHPP 105X19X.19MM. THE (B)(4) DETAIL COMPONENT PRODUCTION PART NUMBER FOR THIS BLADE IS 11-4514-01 (0500-4442-07). LOT 2W331 WAS RELEASED INTO INVENTORY ON NOVEMBER 13, 2012. THERE WERE NO NON-CONFORMANCES DURING MANUFACTURE. ALL INSPECTION REQUIREMENTS WERE MET. THE DEVICE WAS SCRAPPED BY THE USER. NO EXAMINATION OF THE DEVICE WAS POSSIBLE ON THE ACTUAL DEVICE. HOWEVER PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CUSTOMER CONFIRMS THAT THE MOUNTING HUB FRACTURED. ADDITIONALLY, THE SIDE EDGES OF THE SAW BLADE ARE HEAVILY DAMAGED NEAR THE TIP AT THE SAW TEETH. THE DEVICE HISTORY RECORD REVIEW NOTED NO SPONTANEOUS ANOMALIES, REQUEST FOR DEVIATIONS, NON-CONFORMANCES OR OTHER ISSUES WITH THE PRODUCTION OF THIS DEVICE. THE REVIEW OF THE MANUFACTURING PROCESS AND THE ENGINEERING DESIGN NOTED NO SYSTEMIC ISSUES WITH THIS DEVICE. THE CUSTOMER'S REPORTED EVENT WAS THAT THE PART OF THE MOUNTING HUB HAD BROKEN AT THE HUB CONNECTION WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE FOR THIS REPORTED EVENT IS USER ERROR DAMAGE. THE IMPACT DAMAGE TO THE EDGES OF THE SAW BLADE OCCURS DURING USE. THE SIDES OF THE BLADE IMPACT THE METAL CUTTING GUIDE AS THE BLADE OSCILLATES. THE REPEATED HIGH SPEED IMPACT OF BOTH SIDES OF THE CUTTING BLADE AGAINST METAL GUIDE THE BACK CAN STRESS THE MATERIAL AT THE CONNECTION (HUB) TO LEAD TO THE BREAKAGE OF THE HUB. THIS ESPECIALLY SO WHEN THE USER INITIATES A BACK AND FORTH MOTION (SAWING MOTION). THE STRESS TORQUE IS MAGNIFIED WHEN BLADE IMPACT ORIGINATES AT THE SAW TEETH TIP FARTHER AWAY FROM THE MOUNTING HUB. THERE ARE NO RECOMMENDED ACTIONS; THE SEVERITY AND FREQUENCY DO NOT WARRANT FURTHER ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW BLADE BROKE AT THE HUB. THE FACILITY USES ZIMMER SAW BLADE ON THE HALL POWER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473992 OSCILLATING SAW BLADE LINVATEC®/HALL® POWERPRO® OSC GTS LHPP 105 X 19 X 1.19MM GFA SYNVASIVE TECHNOLOGY, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1