BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8871152 · Received August 7, 2019

    Report

    Report Number
    3005985723-2019-00564
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    August 1, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT WHILE MAKING OUR STRAIGHT CUTS AND THE BLADE KEPT FALLING OUT. APPARENTLY IT HAPPENS HERE A LOT. SURGEON REATTACHED BLADE 3 TIMES AND IT FELL OUT ALL 3 TIMES SO I OPENED ANOTHER MAKO KNEE POWER AND USED THAT STRAIGHT SAW ATTACHMENT AND IT WORKED OUT FOR THE REST OF THE CUTS CASE TYPE: TKA. SURGICAL DELAY: X - =15 MINUTES. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: THE 212186 2.7 DEGREE STRAIGHT SAGITAL SAW SHOWS LIGHT WEAR AND TEAR (SMALL SCRATCH AND BURNISH MARKS) ON THE DEVICE. THERE ARE ALSO MARKS ON THE KNOB FROM WHERE THE WRENCH MAKES CONTACT. A PICTURE OF THE DEVICE IS ATTACHED. FUNCTIONAL INSPECTION: THE 212186 STRAIGHT SAW (LOT 35060718 / SERIAL (B)(6)) 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 KEPT FALLING OUT¿ 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: DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED UNDER LOT 35060718 AND 48 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 08/28/2018. A REVIEW OF QT-18-08-0103 REVEALED 02 REJECTED DEVICES WERE RE-INSPECTED AND ACCEPTED INTO FINAL STOCK ON 01/08/2019. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT 35060718 SHOWS 1 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINT IS PR: (B)(4). CONCLUSIONS: THE FAILURE IS CONFIRMED VIA FUNCTIONAL 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.

    Description of Event or Problem · 0

    WAS MAKING OUR STRAIGHT CUTS AND THE BLADE KEPT FALLING OUT. APPARENTLY IT HAPPENS HERE A LOT. SURGEON REATTACHED BLADE 3 TIMES AND IT FELL OUT ALL 3 TIMES SO I OPENED ANOTHER MAKO KNEE POWER AND USED THAT STRAIGHT SAW ATTACHMENT AND IT WORKED OUT FOR THE REST OF THE CUTS. CASE TYPE: TKA. SURGICAL DELAY: X - =15 MINUTES.

    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

    WAS MAKING OUR STRAIGHT CUTS AND THE BLADE KEPT FALLING OUT. APPARENTLY IT HAPPENS HERE A LOT. SURGEON REATTACHED BLADE 3 TIMES AND IT FELL OUT ALL 3 TIMES SO I OPENED ANOTHER MAKO KNEE POWER AND USED THAT STRAIGHT SAW ATTACHMENT AND IT WORKED OUT FOR THE REST OF THE CUTS. CASE TYPE: TKA. SURGICAL DELAY: X - =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664109 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3503692/35060718 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization