BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 9378675 · Received November 26, 2019

    Report

    Report Number
    3005985723-2019-00853
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 4, 2019
    Report Date
    July 2, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT "EXTREMELY LOUD WHEN CUTTING. CASE TYPE: TKA 16-30 MINUTES". PRODUCT EVALUATION AND RESULTS: FUNCTIONAL INSPECTION OF SAW ATTACHMENT CONFIRMED LOUD NOISE. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(6) DEVICES WERE MANUFACTURED UNDER LOT 35031018 AND ALL (B)(6) DEVICES WERE ACCEPTED (INCLUDING SERIAL (B)(6)) INTO FINAL STOCK ON 11/08/2018 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT NUMBER 35031018 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE WAS CONFIRMED VIA INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT "EXTREMELY LOUD WHEN CUTTING. CASE TYPE: TKA, 16-30 MINUTES" PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION CAPA 2127499 HAS BEEN RAISED FOR THE SAME. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED UNDER LOT 35031018 AND ALL (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 11/08/2018 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT NUMBER35031018 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    EXTREMELY LOUD WHEN CUTTING. CASE TYPE: TKA. 16-30 MINUTES.

    Description of Event or Problem · 0

    EXTREMELY LOUD WHEN CUTTING. CASE TYPE: TKA. 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

    EXTREMELY LOUD WHEN CUTTING. CASE TYPE: TKA. 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172011 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 212186 35031018 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization