BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE ANGLED SAGITAL SAW

    MDR report key: 7613635 · Received June 19, 2018

    Report

    Report Number
    3005985723-2018-00377
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    June 14, 2018
    Report Date
    June 21, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032128
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #2 AND FINAL REPORT SUBMITTED TO UPDATE.

    Description of Event or Problem · 0

    AS REPORTED: INITIALLY ANGLED SAW WAS A BIT DIFFICULT TO PLACE INTO SAW ATTACHMENT. DURING CASE THE ANGLED SAW ATTACHMENT WAS STUCK AND COULD REMOVE FROM MICS. SWAPPED OUT AND COMPLETED CASE.TKA PROCEDURE DELAYED 20 MINUTES.***ADDITIONAL INFORMATION***: DURING CASE WHEN WE WERE FINISHED WITH ANGLED SAW ATTACHMENT, THE ATTACHMENT GOT STUCK AND COULD NOT BE REMOVED FROM MICS THEREFORE WE HAD TO SWITCH OUT THE MICS TO RESOLVE PROBLEM. HOWEVER WHEN CASE WAS DONE WE ATTEMPTED TO ATTACH SAW ATTACHMENT TO TWO DIFFERENCE MICS HANDLES AND IT COULDN¿T ATTACH TO EITHER ONE. THEREFORE THE ISSUE WAS WITH THE ANGLED SAW ATTACHMENT.

    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

    AS REPORTED: INITIALLY ANGLED SAW WAS A BIT DIFFICULT TO PLACE INTO SAW ATTACHMENT. DURING CASE THE ANGLED SAW ATTACHMENT WAS STUCK AND COULD REMOVE FROM MICS. SWAPPED OUT AND COMPLETED CASE. TKA PROCEDURE DELAYED 20 MINUTES. ADDITIONAL INFORMATION: DURING CASE WHEN WE WERE FINISHED WITH ANGLED SAW ATTACHMENT, THE ATTACHMENT GOT STUCK AND COULD NOT BE REMOVED FROM MICS THEREFORE WE HAD TO SWITCH OUT THE MICS TO RESOLVE PROBLEM. HOWEVER WHEN CASE WAS DONE WE ATTEMPTED TO ATTACH SAW ATTACHMENT TO TWO DIFFERENCE MICS HANDLES AND IT COULDN¿T ATTACH TO EITHER ONE. THEREFORE THE ISSUE WAS WITH THE ANGLED SAW ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458839 2.7 DEGREE ANGLED SAGITAL SAW STERETOAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3503174 / 35060118 00848486032128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization