BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8227952 · Received January 8, 2019

    Report

    Report Number
    3005985723-2019-00038
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    January 7, 2019
    Report Date
    March 26, 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

    REPORTED EVENT: DURING ANTERIOR CUT OF THE FEMUR THE SAW BLADE FLEW OFF OF THE ROBOT. WE PUT IT BACK ON THE STRAIGHT ATTACHMENT AND TIGHTENED AND IT HAPPENED AGAIN. NO PATIENT HARM. HAD TO OPEN A NEW TKA MICS SET FOR THE STRAIGHT ATTACHMENT. REQUESTING THIS PIECE TO BE REPLACED. SURGICAL DELAY =15 MINUTES. CASE TYPE: TKA. FUNCTIONAL INSPECTION: SHOWS THAT THE ATTACHMENT KNOB WHEN TURNED DOES CLAMP THE BLADE, HOWEVER, THE RATCHETING PAWL IS NOT CLICKING TO LOCK THE KNOB. THE FAILURE MODE IS CONFIRMED. VISUAL INSPECTION: SHOWS THAT THE PLUNGER THAT PUSHES ON THE RATCHETING PAWL TO ENGAGE IT WITH THE RATCHETING HOUSING IS STUCK. DIMENSIONAL INSPECTION: NOT PERFORMED AS THE ITEM HAS BEEN USED AND THE DIMENSIONS AND TOLERANCES ON THE PRINT ARE NO LONGER ACCURATELY REPRESENTED BY THE PART. 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: 10-04-2018. DEVICES MANUFACTURED: 47. DEVICES FAILED INSPECTION: 4. NC/NPR/QT NUMBERS: QT18-10-0033. PRODUCT HISTORY REVIEW SHOWS THE NON-CONFORMANCE(S) IS/ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N: 212186, LOT NUMBER: 35010918 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 BLADE NOT STAYING LOCKED WAS CONFIRMED. THE FAILURE WAS TRACED TO THE RATCHETING PAWL BEING STUCK. THE ISSUE WAS OBSERVED DURING A CASE AND RESULTED IN A DELAY OF UP TO 15 MINUTES. 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 ANTERIOR CUT OF THE FEMUR THE SAW BLADE FLEW OFF OF THE ROBOT. WE PUT IT BACK ON THE STRAIGHT ATTACHMENT AND TIGHTENED AND IT HAPPENED AGAIN. NO PATIENT HARM. HAD TO OPEN A NEW TKA MICS SET FOR THE STRAIGHT ATTACHMENT. REQUESTING THIS PIECE TO BE REPLACED. SURGICAL DELAY =15 MINUTES. CASE TYPE: TKA.

    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 ANTERIOR CUT OF THE FEMUR THE SAW BLADE FLEW OFF OF THE ROBOT. WE PUT IT BACK ON THE STRAIGHT "ATTACHEMENT" AND TIGHTENED AND IT HAPPENED AGAIN. NO PATIENT HARM. HAD TO OPEN A NEW TKA MICS SET FOR THE STRAIGHT ATTACHMENT. REQUESTING THIS PIECE TO BE REPLACED. SURGICAL DELAY- =15 MINUTES. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21741 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35010918 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization