BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8572994 · Received May 2, 2019

    Report

    Report Number
    3005985723-2019-00328
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 16, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: STRAIGHT "SAW BLADE" ATTACHMENT STOPPED WORKING IN MID CUT. CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES. FUNCTIONAL INSPECTION: TURNING THE INPUT SHAFT BY BAND DOES NOT PRODUCE ANY MOTION AT THE BLADE PLATFORM. THE FAILURE MODE IS CONFIRMED. VISUAL INSPECTION: SHOWS THAT THE INPUT SHAFT BEARINGS HAVE BROKEN APART AND SLIPPED OFF THE SHAFT. SEE ATTACHED PICTURE. DIMENSIONAL INSPECTION: NOT PERFORMED AS THE VISUAL AND FUNCTIONAL INSPECTION ARE SUFFICIENT TO CONFIRM THE FAILURE. MATERIAL ANALYSIS: NOT PERFORMED AS NO MATERIAL FAILURE IS ALLEGED. PRODUCT HISTORY REVIEW: PRODUCT HISTORY REVIEW RESPECTIVELY SHOWS THE NUMBER OF DEVICES MANUFACTURED, DEVICES THAT FAILED INSPECTION, AND THEIR NC/NPR/QT NUMBERS IF APPLICABLE. DATE INSPECTED: 01-29-2019, DEVICES MANUFACTURED: (B)(4), DEVICES FAILED INSPECTION: 0, NC/NPR/QT NUMBERS: 0. PRODUCT HISTORY REVIEW SHOWS NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N: 212186, LOT NUMBER: 35030119 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINTS RELATED TO P/N: 212186 WILL BE TRACKED BY TREND REQUEST# (B)(4). CONCLUSION: THE COMPLAINT OF THE SAW ATTACHMENT NOT WORKING WAS CONFIRMED. THE FAILURE WAS TRACED TO THE BEARINGS ON THE INPUT SHAFT BREAKING APART. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    STRAIGHT "SAW BLADE" ATTACHMENT STOPPED WORKING IN MID CUT. CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES.

    Additional Manufacturer Narrative · 1

    ¿AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.¿

    Description of Event or Problem · 1

    STRAIGHT SAWBLADE ATTACHMENT STOPPED WORKING IN MID CUT. CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368207 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35030119 / 3505311 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization