BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE ANGLED SAGITAL SAW

    MDR report key: 8288745 · Received January 30, 2019

    Report

    Report Number
    3005985723-2019-00078
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 8, 2019
    Report Date
    May 30, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032128
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: TKA. EVENT DESCRIPTION: RIGHT ANGLE SAW ATTACHMENT UNABLE TO HOLD SAW DURING CUTTING. FAILED TO SECURE COMPLETELY. SURGICAL DELAY 1 MIN. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. VISUAL INSPECTION: VISUAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. MATERIAL ANALYSIS: MATERIAL ANALYSIS COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. 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: 06-13-2016. DEVICES MANUFACTURED: 22. DEVICES FAILED INSPECTION: 6. NC/NPR/QT NUMBERS: QT16-07-0072. 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: 212480, LOT NUMBER: 35010716 SHOWS 2 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT # (B)(4). COMPLAINTS RELATED TO P/N: 212480 WILL BE TRACKED BY TREND REQUEST# (B)(4). CONCLUSION: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    TKA. EVENT DESCRIPTION: RIGHT ANGLE SAW ATTACHMENT UNABLE TO HOLD SAW DURING CUTTING. FAILED TO SECURE COMPLETELY. SURGICAL DELAY 1 MIN.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: RIGHT ANGLE SAW ATTACHMENT UNABLE TO HOLD SAW DURING CUTTING. FAILED TO SECURE COMPLETELY. SURGICAL DELAY 1 MIN.

    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

    TKA. EVENT DESCRIPTION: RIGHT ANGLE SAW ATTACHMENT UNABLE TO HOLD SAW DURING CUTTING. FAILED TO SECURE COMPLETELY. SURGICAL DELAY 1 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83212 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35010716/3500205 00848486032128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization