BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8946569 · Received August 29, 2019

    Report

    Report Number
    3005985723-2019-00612
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 10, 2019
    Report Date
    December 10, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. IT WAS REPORTED THAT STRAIGHT SAW ATTACHMENT BROKE DURING LAB. (CADAVER LAB). PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: THE 212186 2.7 DEGREE STRAIGHT SAGITAL SAW SHOWS NO WEAR OR AND TEAR. A PICTURE OF THE DEVICE IS ATTACHED. FUNCTIONAL INSPECTION: THE 212186 STRAIGHT SAW (LOT: 35060219 / SERIAL: (B)(6) EASILY LOCKED INTO IN A KNOWN GOOD 209063 MICS HANDPIECE. A KNOWN GOOD 116170 STANDARD 2MM BLADE WAS INSTALLED IN THE 212186 STRAIGHT SAW; THE LOCKING KNOB TURNS NORMALLY WITH THE CLICKING FEELING ASSOCIATED WITH THE RATCHETING PAWL LOCKING. THE MICS WAS POWERED ON AND THE BLADE SWUNG NORMALLY. A PICTURE OF THE DEVICE INSTALLED IN A MICS IS ATTACHED. THE FAILURE MODE ¿STRAIGHT SAW ATTACHMENT BROKE DURING LAB¿ WAS NOT CONFIRMED. DIMENSIONAL INSPECTION: NOT PERFORMED AS NO DIMENSIONAL FAILURE IS ALLEGED. MATERIAL ANALYSIS: NOT PERFORMED AS NO MATERIAL FAILURE IS ALLEGED. PRODUCT HISTORY REVIEW: 1. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 29 DEVICES WERE MANUFACTURED AND ALL WERE ACCEPTED INTO FINAL STOCK ON 03-13-2019 WITH NO REPORTED DISCREPANCIES. 2. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 09 DEVICES WERE MANUFACTURED AND ALL WERE ACCEPTED INTO FINAL STOCK ON 03-11-2019 WITH NO REPORTED DISCREPANCIES. 3. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 10 DEVICES WERE MANUFACTURED AND ALL WERE ACCEPTED INTO FINAL STOCK ON 03-05-2019 WITH NO REPORTED DISCREPANCIES. 4. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 2 DEVICES WERE MANUFACTURED AND ALL WERE ACCEPTED INTO FINAL STOCK ON 03-08-2019 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N: 212186, LOT: 35060219 SHOWS 0 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: PER D03391, PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE FAILURE WAS NOT CONFIRMED VIA VISUAL AND FUNCTIONAL INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    STRAIGHT SAW ATTACHMENT BROKE DURING LAB. (CADAVER LAB). CASE TYPE: TKA. AS PER SERVICE MAX: THIS IS A CLINICAL UNIT.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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 SAW ATTACHMENT BROKE DURING LAB. (CADAVER LAB). CASE TYPE: TKA. AS PER SERVICE MAX: THIS IS A CLINICAL UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738201 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35060219 / 3505774 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization