BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8602454 · Received May 12, 2019

    Report

    Report Number
    3005985723-2019-00355
    Event Type
    Malfunction
    Date Received
    May 12, 2019
    Date of Event
    April 29, 2019
    Report Date
    July 29, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: HAD ISSUE WITH MICS AFTER 1ST TWO CUTS- AFTER NEW MICS ON THE ANGLE BLADE MANIFOLD WORKED BUT THE STRAIGHT MANIFOLD WOULDN¿T WORK AT ALL. CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES. FUNCTIONAL INSPECTION: SHOWS THAT THE ATTACHMENT WITH A BLADE ATTACHED AND SECURED TO A MICS HANDPIECE RUNS NORMALLY. THE FAILURE MODE IS NOT CONFIRMED. VISUAL INSPECTION: SHOWS NO DAMAGE TO THE ATTACHMENT. 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: 6/13/2018, 8/14/2018. DEVICES MANUFACTURED: (B)(4). DEVICES FAILED INSPECTION: 0, 0. NC/NPR/QT NUMBERS: 0. 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: 35050118 SHOWS 2 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT # (B)(4). COMPLAINTS RELATED TO P/N: 212186 WILL BE TRACKED BY TREND REQUEST# (B)(4). CONCLUSION: THE COMPLAINT OF THE SAW ATTACHMENT NOT WORKING PROPERLY WAS CONFIRMED. 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

    HAD ISSUE WITH MICS AFTER 1ST TWO CUTS- AFTER NEW MICS ON THE ANGLE BLADE MANIFOLD WORKED BUT THE STRAIGHT MANIFOLD WOULDN¿T WORK AT ALL. CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES.

    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

    HAD ISSUE WITH MICS AFTER 1ST TWO CUTS- AFTER NEW MICS ON THE ANGLE BLADE MANIFOLD WORKED BUT THE STRAIGHT MANIFOLD WOULDN¿T WORK AT ALL. CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395776 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35050118 / 3503120 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization