BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 7845609 · Received September 5, 2018

    Report

    Report Number
    3005985723-2018-00521
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 24, 2018
    Report Date
    February 13, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: BLADE KEPT COMING OFF OF THE STRAIGHT BLADE ATTACHMENT DURING THE CASE. WHILE THE SURGEON WAS MAKING HIS CUTS, THE SAW BLADE CAME OFF. THE SURGICAL TECH TIGHTENED THE BLADE BACK ONTO THE ATTACHMENT AND THEN THE BLADE CAME OFF ONCE MORE WHEN THE SURGEON WAS ATTEMPTING TO MAKE HIS CUTS. CASE TYPE: TKA. DEVICE EVALUATION AND RESULTS: FUNCTIONAL INSPECTION: SHOWS THAT THE LOCKING KNOB DOES NOT STAY LOCKED. THE FAILURE MODE IS CONFIRMED. VISUAL INSPECTION: SHOWS NORMAL WEAR AND TEAR DAMAGE TO THE PART AS WELL AS THE RATCHETING PAWL THAT KEEPS THE BLADE LOCKED IS STUCK OPEN. SEE ATTACHED PICTURE. THE INSPECTION ALSO SHOWS WEAR MARKS ON THE KNOB FROM WHERE THE KNOB WRENCH MAKES CONTACT. DIMENSIONAL INSPECTION: NOT PERFORMED AS THE ITEM HAS BEEN USED AND THE DIMENSIONS AND TOLERANCES ON THE PRINT ARE NO LONGER ACCURATELY REPRESENTED BY THE PART. MATERIAL ANALYSIS: NOT PERFORMED AS NO MATERIAL FAILURE IS ALLEGED. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 08/31/17 8 DEVICES WERE INSPECTED AND 6 DEVICES WERE PLACED ON: QT17-08-0131. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT NUMBER 3501453/35060417 SHOWS 5 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). TRACKING OF COMPLAINTS RELATED TO THE 212186 PART NUMBER WILL BE TRACKED THROUGH TREND REQUEST # (B)(4). CONCLUSIONS: THE REPORT OF THE BLADE NOT STAYING LOCKED ON A SAW ATTACHMENT WAS CONFIRMED. THE ISSUE WAS TRACED TO A STUCK PAWL INSIDE THE KNOB ASSEMBLY AND MOST LIKELY CAUSED BY NORMAL WEAR AND TEAR. THE ISSUE WAS OBSERVED DURING THE CASE AND DID NOT AFFECT THE PATIENT OR SUCCESSFUL COMPLETION OF THE CASE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    BLADE KEPT COMING OFF OF THE STRAIGHT BLADE ATTACHMENT DURING THE CASE. WHILE THE SURGEON WAS MAKING HIS CUTS, THE SAW BLADE CAME OFF. THE SURGICAL TECH TIGHTENED THE BLADE BACK ONTO THE ATTACHMENT AND THEN THE BLADE CAME OFF ONCE MORE WHEN THE SURGEON WAS ATTEMPTING TO MAKE HIS CUTS. 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. PENDING INVESTIGATION.

    Description of Event or Problem · 1

    BLADE KEPT COMING OFF THE STRAIGHT BLADE ATTACHMENT DURING THE CASE. WHILE THE SURGEON WAS MAKING HIS CUTS, THE SAW BLADE CAME OFF. THE SURGICAL TECH TIGHTENED THE BLADE BACK ONTO THE ATTACHMENT AND THEN THE BLADE CAME OFF ONCE MORE WHEN THE SURGEON WAS ATTEMPTING TO MAKE HIS CUTS. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687754 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3501453/35060417 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization