BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE ANGLED SAGITAL SAW

    MDR report key: 8485716 · Received April 4, 2019

    Report

    Report Number
    3005985723-2019-00280
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 18, 2019
    Report Date
    May 30, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032128
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: ANGLED SAW ATTACHMENT WOULD NOT SECURE THE BLADE AND IT WOULD FLY OFF AS SOON AS THE CUTTER WAS ENGAGED CASE TYPE: TKA, SURGICAL DELAY: =15 MINUTES. DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING? YES/NO; AS PER THE MPS: YES. COULD THE SAWBLADE HAVE HAD THE POTENTIAL FOR FALLING INTO THE WOUND AND CAUSE HARM TO PATIENT? AS PER THE MPS: THERE WAS POTENTIAL FOR THE SAWBLADE TO FALL INTO THE WOUND, HOWEVER IMO THE POTENTIAL FOR PATIENT HARM WOULD BE RELATIVELY LOW. FUNCTIONAL INSPECTION: SHOWS THAT THE ATTACHMENT KNOB WHEN TURNED DOES CLAMP THE BLADE, HOWEVER, THE RATCHETING PAWL IS NOT CLICKING TO LOCK THE KNOB. THE FAILURE MODE IS CONFIRMED. VISUAL INSPECTION: SHOWS A STUCK RATCHETING PAWL PLUNGER. 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: PRODUCT HISTORY REVIEW RESPECTIVELY SHOWS THE NUMBER OF DEVICES MANUFACTURED, DEVICES THAT FAILED INSPECTION, AND THEIR NC/NPR/QT NUMBERS IF APPLICABLE. DATE INSPECTED: 02-06-2019, DEVICES MANUFACTURED: 45, DEVICES FAILED INSPECTION: 7, NC/NPR/QT NUMBERS: QT19-02-0018. 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: 212480, LOT NUMBER: 35040119 SHOWS 1 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT # 2015724. COMPLAINTS RELATED TO P/N: 212480 WILL BE TRACKED BY TREND REQUEST# 1191. CONCLUSION: THE COMPLAINT OF THE BLADE NOT STAYING LOCKED WAS CONFIRMED. THE FAILURE WAS TRACED TO THE RATCHETING PAWL PLUNGER BEING STUCK. THE ISSUE WAS OBSERVED DURING THE CASE, THERE WAS NO HARM AND THE CASE WAS COMPLETED SUCCESSFULLY. 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

    ANGLED SAW ATTACHMENT WOULD NOT SECURE THE BLADE AND IT WOULD FLY OFF AS SOON AS THE CUTTER WAS ENGAGED CASE TYPE: TKA SURGICAL DELAY: =15 MINUTES DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING? YES/NO: AS PER THE MPS: YES. COULD THE SAWBLADE HAVE HAD THE POTENTIAL FOR FALLING INTO THE WOUND AND CAUSE HARM TO PATIENT? AS PER THE MPS: THERE WAS POTENTIAL FOR THE SAWBLADE TO FALL INTO THE WOUND, HOWEVER IMO THE POTENTIAL FOR PATIENT HARM WOULD BE RELATIVELY LOW.

    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

    ANGLED SAW ATTACHMENT WOULD NOT SECURE THE BLADE AND IT WOULD FLY OFF AS SOON AS THE CUTTER WAS ENGAGED. CASE TYPE: TKA SURGICAL DELAY: 15 MINUTES. DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING? YES/NO AS PER THE MPS: YES COULD THE SAWBLADE HAVE HAD THE POTENTIAL FOR FALLING INTO THE WOUND AND CAUSE HARM TO PATIENT? AS PER THE MPS: THERE WAS POTENTIAL FOR THE SAWBLADE TO FALL INTO THE WOUND, HOWEVER IMO THE POTENTIAL FOR PATIENT HARM WOULD BE RELATIVELY LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274445 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35040119/ 3505320 00848486032128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization