BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8645335 · Received May 28, 2019

    Report

    Report Number
    3005985723-2019-00390
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 7, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: ATTACHMENT WOULD NOT FULLY LOCK DOWN ONTO SAW BLADE. COULD NOT PASS ROBOT CHECKPOINT BEFORE CUTTING CASE TYPE: TKA SURGICAL DELAY: APPROX. 20 MINUTES UPDATE: ""THE PATIENT WAS UNDER ANESTHESIA DURING THE TIME OF THE EVENT"" DID THE SAW ATTACHMENT FALL OUT OF THE MICS HANDPIECE DURING CUTTING? YES/NO. AS PER THE MPS ""NO IT DID NOT"". 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 CAP 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: PRODUCT HISTORY REVIEW RESPECTIVELY SHOWS THE NUMBER OF DEVICES MANUFACTURED, DEVICES THAT FAILED INSPECTION, AND THEIR NC/NPR/QT NUMBERS IF APPLICABLE. DATE INSPECTED: 03-06-2017, DEVICES MANUFACTURED: 50, DEVICES FAILED INSPECTION: 7, NC/NPR/QT NUMBERS: QT17-03-0016. PRODUCT HISTORY REVIEW SHOWS THE NON-CONFORMANCE(S) IS/ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N: 212186, LOT NUMBER: 35010217 SHOWS 3 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT # (B)(4), (B)(4), (B)(4). COMPLAINTS RELATED TO P/N: 212186 WILL BE TRACKED BY TREND REQUEST# 1191. CONCLUSION: THE COMPLAINT OF A SAW ATTACHMENT NOT CLAMPING THE BLADE PROPERLY WAS CONFIRMED. THE ISSUE WAS TRACED TO A BROKEN CAP PIN. 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

    ATTACHMENT WOULD NOT FULLY LOCK DOWN ONTO SAW BLADE. COULD NOT PASS ROBOT CHECKPOINT BEFORE CUTTING. CASE TYPE: TKA. SURGICAL DELAY: APPROX. 20 MINUTES UPDATE: "THE PATIENT WAS UNDER ANESTHESIA DURING THE TIME OF THE EVENT" DID THE SAW ATTACHMENT FALL OUT OF THE MICS HANDPIECE DURING CUTTING? YES/NO. AS PER THE MPS "NO IT DID NOT".

    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

    ATTACHMENT WOULD NOT FULLY LOCK DOWN ONTO SAW BLADE. COULD NOT PASS ROBOT CHECKPOINT BEFORE CUTTING. CASE TYPE: TKA. SURGICAL DELAY: APPROX. 20 MINUTES. UPDATE: "THE PATIENT WAS UNDER ANESTHESIA DURING THE TIME OF THE EVENT" DID THE SAW ATTACHMENT FALL OUT OF THE MICS HANDPIECE DURING CUTTING? YES/NO. AS PER THE MPS "NO IT DID NOT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439038 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35010217/ 3500856 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization