BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 10574524 · Received September 23, 2020

    Report

    Report Number
    3005985723-2020-00303
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 31, 2020
    Report Date
    November 23, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE - 1) STRAIGHT SAW ATTACHMENT HAD OIL LEAKING FROM IT WHEN OPENING TRAYS PRE-OP. 2) BLUE SQUARE DRIVER: HANDLE MOVING INDEPENDENTLY FROM THE DRIVER. NO SURGICAL DELAY. CASE TYPE / APPLICATION: TKA PRODUCT INSPECTION ¿ VISUAL INSPECTION CONFIRMED THE EVENT. THERE IS OIL RESIDUE ON THE ATTACHMENT. SEE ATTACHED IMAGE. PRODUCT HISTORY REVIEW ¿ REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED AND 50 WERE ACCEPTED (INCLUDING SERIAL (B)(6) INTO FINAL STOCK ON 01/16/2018 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW ¿ A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT NUMBER 35011217 SHOWS 00 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION ¿ THE EVENT WAS CONFIRMED VIA VISUAL 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

    1) STRAIGHT SAW ATTACHMENT HAD OIL LEAKING FROM IT WHEN OPENING TRAYS PRE-OP. 2) BLUE SQUARE DRIVER: HANDLE MOVING INDEPENDENTLY FROM THE DRIVER. NO SURGICAL DELAY. 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

    STRAIGHT SAW ATTACHMENT HAD OIL LEAKING FROM IT WHEN OPENING TRAYS PRE-OP. BLUE SQUARE DRIVER: HANDLE MOVING INDEPENDENTLY FROM THE DRIVER. NO SURGICAL DELAY. CASE TYPE / APPLICATION: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036630 2.7 DEGREE STRAIGHT SAGITAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 212186 35011217 / 3502814 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other