BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 11720621 · Received April 23, 2021

    Report

    Report Number
    3005985723-2021-00080
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 31, 2021
    Report Date
    September 24, 2021
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE - LUBRICANT WAS FOUND LEAKING FROM SAW ATTACHMENTS. THE SPD MANAGER INSISTS ALL SAW ATTACHMENTS BE EXCHANGED. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE / APPLICATION: TKA. PRODUCT INSPECTION ¿ FUNCTIONAL INSPECTION DID NOT CONFIRM THE EVENT. GREASE WAS NOT PRESENT. PRODUCT HISTORY REVIEW - REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED UNDER LOT NO 35040317 AND ALL DEVICES WERE REJECTED. REVIEW OF QT 17-04-0078 REVEALED THAT 48 OUT OF 50 DEVICES WERE ACCEPTED (INCLUDING 3501159) INTO FINAL STOCK. NON CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THE EVENT. COMPLAINT HISTORY REVIEW ¿ A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212480, LOT NUMBER 35040317 SHOWS 00 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. NC/CAPA HISTORY REVIEW - 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. CONCLUSION ¿ PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE FAILURE WAS NOT CONFIRMED VIA INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    LUBRICANT WAS FOUND LEAKING FROM SAW ATTACHMENTS. THE SPD MANAGER INSISTS ALL SAW ATTACHMENTS BE EXCHANGED. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE / APPLICATION: 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

    LUBRICANT WAS FOUND LEAKING FROM SAW ATTACHMENTS. THE SPD MANAGER INSISTS ALL SAW ATTACHMENTS BE EXCHANGED. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE / APPLICATION: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616434 2.7 DEGREE STRAIGHT SAGITAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 212186 35040317 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other