BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8955602 · Received September 3, 2019

    Report

    Report Number
    3005985723-2019-00633
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 27, 2019
    Report Date
    November 28, 2019
    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 EVENT: IT WAS REPORTED THAT THE BLADE CONTINUED TO POP OUT WHILE CUTTING. BLADE WON¿T LOCK INTO ATTACHMENT PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: THE 212186 2.7 DEGREE STRAIGHT SAGITAL SAW SHOWS WEAR AND TEAR (A FEW SMALL SCRATCHES AND BURNISH MARKS) ON THE DEVICE. THERE ARE ALSO BURNISH MARKS ON THE OUTSIDE DIAMETER OF THE KNOB. FURTHER INSPECTION SHOWED THAT THE RATCHETING PAWL IS STUCK. A PICTURE OF THE DEVICE IS ATTACHED. FUNCTIONAL INSPECTION: THE 212186 STRAIGHT SAW (LOT 35030617 / SERIAL (B)(4)) EASILY LOCKED INTO IN A KNOWN GOOD 209063 MICS HANDPIECE. A KNOWN GOOD 116170 STANDARD 2MM BLADE WAS INSTALLED IN THE 212186 STRAIGHT SAW. THE LOCKING KNOB TURNS BUT THE CLICKING FEELING ASSOCIATED WITH THE RATCHETING PAWL LOCKING COULD NOT BE FELT. THE MICS WAS POWERED ON AND THE BLADE CAME LOOSE AFTER A FEW SECONDS. A PICTURE OF THE DEVICE INSTALLED IN A MICS IS ATTACHED. THE FAILURE MODE ¿BLADE CONTINUED TO POP OUT WHILE CUTTING¿ WAS CONFIRMED. DIMENSIONAL INSPECTION: NOT PERFORMED AS NO DIMENSIONAL FAILURE IS ALLEGED. MATERIAL ANALYSIS: NOT PERFORMED AS NO MATERIAL FAILURE IS ALLEGED. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED AND 49 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 07/17/2017. A REVIEW OF QT17-07-0041 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT NUMBER 35030617 SHOWS 04 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT INVESTIGATIONS(S) PR: (B)(4). CONCLUSIONS: THE FAILURE MODE ¿BLADE CONTINUED TO POP OUT WHILE CUTTING¿ WAS CONFIRMED. THE FAILURE WAS TRACED TO A STUCK RATCHETING PAWL. 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 NCS OR CAPAS ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    BLADE CONTINUED TO POP OUT WHILE CUTTING. BLADE WON¿T LOCK INTO ATTACHMENT. CASE TYPE: TKA. SURGICAL DELAY: =15 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

    BLADE CONTINUED TO POP OUT WHILE CUTTING. BLADE WON¿T LOCK INTO ATTACHMENT. CASE TYPE: TKA. SURGICAL DELAY: =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751101 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35030617 / 3501745 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization