BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8955600 · Received September 3, 2019

    Report

    Report Number
    3005985723-2019-00632
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 23, 2019
    Report Date
    December 26, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: WHEN ATTEMPTING BONE CUTS, THE SAW BLADE DID NOT STAY IN STRAIGHT SAW ATTACHMENT. UNABLE TO TIGHTEN DOWN. CASE TYPE: TKA. UPDATE: THE ATTACHMENT DID NOT DETACH FROM THE HANDPIECE. ONLY THE SAW BLADE DETACHED. THE SAW BLADE JUST FELL OUT TWICE (FIRST ON STERILE DRAPE, THE SECOND TIME ON THE FLOOR) WHEN USING THE STRAIGHT ATTACHMENT. THE SAW BLADE WORKED FINE WITH THE ANGLED ATTACHMENT. ANOTHER BLADE WAS OPENED AND USED WITH A DIFFERENT STRAIGHT ATTACHMENT AND IT WORKED. FUNCTIONAL INSPECTION: SHOWS THAT THE LOCKING KNOB TURNS FREELY AND THERE IS NO MOVEMENT FROM THE BLADE LOCKING CLAMP. THE FAILURE MODE IS CONFIRMED. VISUAL INSPECTION: SHOWS THAT THE CAM PIN IS BROKEN. SEE ATTACHED PICTURE. THERE ARE ALSO MARKS ON THE KNOB FROM WHERE THE 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 THE FAILURE IS CONSISTENT WITH EXCESSIVE FORCE APPLIED BY THE KNOB. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED AND ALL WERE ACCEPTED INTO FINAL STOCK ON 01/16/18 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT NUMBER 35011217 SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINTS ARE (B)(4). CONCLUSIONS: THE FAILURE IS CONFIRMED VIA VISUAL AND 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

    WHEN ATTEMPTING BONE CUTS, THE SAW BLADE DID NOT STAY IN STRAIGHT SAW ATTACHMENT. UNABLE TO TIGHTEN DOWN. CASE TYPE: TKA. UPDATE: THE ATTACHMENT DID NOT DETACH FROM THE HANDPIECE. ONLY THE SAW BLADE DETACHED. THE SAW BLADE JUST FELL OUT TWICE (FIRST ON STERILE DRAPE, THE SECOND TIME ON THE FLOOR) WHEN USING THE STRAIGHT ATTACHMENT. THE SAW BLADE WORKED FINE WITH THE ANGLED ATTACHMENT. ANOTHER BLADE WAS OPENED AND USED WITH A DIFFERENT STRAIGHT ATTACHMENT AND IT WORKED.

    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

    WHEN ATTEMPTING BONE CUTS, THE SAW BLADE DID NOT STAY IN STRAIGHT SAW ATTACHMENT. UNABLE TO TIGHTEN DOWN. CASE TYPE: TKA. UPDATE: THE ATTACHMENT DID NOT DETACH FROM THE HANDPIECE. ONLY THE SAW BLADE DETACHED. THE SAW BLADE JUST FELL OUT TWICE (FIRST ON STERILE DRAPE, THE SECOND TIME ON THE FLOOR) WHEN USING THE STRAIGHT ATTACHMENT. THE SAW BLADE WORKED FINE WITH THE ANGLED ATTACHMENT. ANOTHER BLADE WAS OPENED AND USED WITH A DIFFERENT STRAIGHT ATTACHMENT AND IT WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751096 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3502823 / 35011217 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization