BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE ANGLED SAGITAL SAW

    MDR report key: 8660232 · Received May 31, 2019

    Report

    Report Number
    3005985723-2019-00401
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 7, 2019
    Report Date
    February 24, 2026
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032128
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE SAW ATTACHMENT COULD NOT HOLD SAW BLADE. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT NO 35010818 AND (B)(4) OUT OF (B)(4) ACCEPTED INTO FINAL STOCK ON 09/23/2018. REVIEW OF QT 18-09-0113 REVEALED THAT THE NON CONFORMANCE WAS NOT RELATED TO THE FAILURE ALLEGED IN THE COMPLAINTS, (B)(4) OUT OF (B)(4) WERE ACCEPTED INTO FINAL STOCK ON 08/28/2019. REVIEW OF QT 18-09-0113 REVEALED THAT THE NON CONFORMANCE WAS NOT RELATED TO THE FAILURE ALLEGED IN THE COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212480, LOT NUMBER 35010818 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 : PRODUCT WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    WHEN CUTTING BONE USING THE ANGLED SAW BLADE ATTACHMENT, THE BLADE KEPT SPITTING OUT, EVEN AFTER SCRUB TECH TIGHTENED DOWN THE BLADE USING THE HEX KEY. OPENED ANOTHER TRAY, PULLED OUT ANOTHER ANGLED SAW ATTACHMENT, AND THAT ONE WORKED APPROPRIATELY. AFTER CASE EXAMINED THE ATTACHMENT, AND NOTICED THAT THE RATCHETING NOISE SOUNDED SLIGHTLY DIFFERENT AND THAT YOU COULD OVER TORQUE THE TIGHTENING FUNCTION. SURGICAL DELAY APPROXIMATELY 1-2 MINUTES. CASE TYPE: 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

    WHEN CUTTING BONE USING THE ANGLED SAW BLADE ATTACHMENT, THE BLADE KEPT SPITTING OUT, EVEN AFTER SCRUB TECH TIGHTENED DOWN THE BLADE USING THE HEX KEY. OPENED ANOTHER TRAY, PULLED OUT ANOTHER ANGLED SAW ATTACHMENT, AND THAT ONE WORKED APPROPRIATELY. AFTER CASE EXAMINED THE ATTACHMENT, AND NOTICED THAT THE RATCHETING NOISE SOUNDED SLIGHTLY DIFFERENT AND THAT YOU COULD OVER TORQUE THE TIGHTENING FUNCTION. SURGICAL DELAY APPROXIMATELY 1-2 MINUTES. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453985 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3503805 / 35010818 00848486032128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization