BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 7134747 · Received December 20, 2017

    Report

    Report Number
    3005985723-2017-00635
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 13, 2017
    Report Date
    May 17, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: DURING CUTS, WE WENT TO SWITCH THE BLADE FROM ANGLED TO STRAIGHT SAW ATTACHMENT. THE BUTTON WOULD DEPRESS SLIGHTLY TO TIGHTEN THE BLADE BUT WE WERE UNABLE TO GET THE TOOL TO FULLY SEAT AND TIGHTEN THE BLADE ONTO IT TO CONTINUE OUR CUTS. WE HAD TO FLASH OUR FIRST CASES SAW ATTACHMENT. TKA CASE DELAYED FOR 30 MINUTES. DEVICE EVALUATION AND RESULTS: FUNCTIONAL INSPECTION SHOWS THAT THE KNOB TURNS BUT THERE IS NO RESULTING MOTION FORM THE BLADE CLAMP. VISUAL INSPECTION SHOWS THAT THE CAM PIN WHICH CONNECTS THE LOCKING KNOB TO RATCHETING HOUSING TO OPEN AND CLOSE THE BLADE CLAMP IS BROKEN. SEE ATTACHED PICTURE. THE INSPECTION ALSO SHOWS WEAR MARKS ON THE KNOB FROM WHERE THE KNOB WRENCH MAKES CONTACT. THIS FAILURE IS CONSISTENT WITH EXCESSIVE FORCE APPLIED TO THE KNOB BY THE WRENCH. PRODUCT HISTORY REVIEW A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 05/31/17 50 DEVICES WERE INSPECTED AND 3 DEVICES WERE PLACED ON: QT17-06-0030. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT NUMBER 3501513 / 35010517 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 212186 PART NUMBER WILL BE TRACKED THROUGH TREND REQUEST # (B)(4). CONCLUSIONS: THE ISSUE OCCURRED DURING A CASE AND CAUSED A 30 MINUTE DELAY. THERE WAS NO FURTHER HARM AND THE CASE WAS COMPLETED SUCCESSFULLY. 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

    DURING CUTS, WE WENT TO SWITCH THE BLADE FROM ANGLED TO STRAIGHT SAW ATTACHMENT. THE BUTTON WOULD DEPRESS SLIGHTLY TO TIGHTEN THE BLADE BUT WE WERE UNABLE TO GET THE TOOL TO FULLY SEAT AND TIGHTEN THE BLADE ONTO IT TO CONTINUE OUR CUTS. WE HAD TO FLASH OUR FIRST CASES SAW ATTACHMENT. TKA CASE DELAYED FOR 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

    DURING CUTS, WE WENT TO SWITCH THE BLADE FROM ANGLED TO STRAIGHT SAW ATTACHMENT. THE BUTTON WOULD DEPRESS SLIGHTLY TO TIGHTEN THE BLADE BUT WE WERE UNABLE TO GET THE TOOL TO FULLY SEAT AND TIGHTEN THE BLADE ONTO IT TO CONTINUE OUR CUTS. WE HAD TO FLASH OUR FIRST CASES SAW ATTACHMENT. TKA CASE DELAYED FOR 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915593 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3501513 / 35010517

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization