BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8253151 · Received January 16, 2019

    Report

    Report Number
    3005985723-2019-00061
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 18, 2018
    Report Date
    April 15, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: BLADE WOULD NOT STAY ATTACHED. CASE TYPE: TKA. FUNCTIONAL INSPECTION: SHOWS THAT THE BLADE IS CLAMPED PROPERLY IN THE ATTACHMENT AND STAYS LOCKED WHILE RUNNING. THE FAILURE MODE IS NOT CONFIRMED. VISUAL INSPECTION: SHOWS NORMAL WEAR AND TEAR DAMAGE TO THE PART. SEE ATTACHED PICTURE. DIMENSIONAL INSPECTION: NOT PERFORMED AS FUNCTIONAL AND VISUAL INSPECTION WERE SUFFICIENT TO REFUTE THE COMPLAINT. 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: 1/22/2019, 1/9/2019, 12/20/2019, 12/19/2018. DEVICES MANUFACTURED: 12, 14, 9, 20. DEVICES FAILED INSPECTION: 12, 0, 9, 20. NC/NPR/QT NUMBERS: QT19-01-0076, QT18-12-0085, QT18-12-0077. 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: 35021218/3504741 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION.COMPLAINTS RELATED TO P/N: 212186 WILL BE TRACKED BY TREND REQUEST# 1191. CONCLUSION: THE REPORT OF THE BLADE COMING LOOSE ON THE SAW ATTACHMENT WAS NOT CONFIRMED. THE ISSUE OCCURRED DURING A CASE BUT DID NOT CAUSE ANY 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

    BLADE WOULD NOT STAY ATTACHED. 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

    BLADE WOULD NOT STAY ATTACHED. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44711 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3504741 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization