BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE ANGLED SAGITAL SAW

    MDR report key: 8392456 · Received March 5, 2019

    Report

    Report Number
    3005985723-2019-00209
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 20, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #2 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS G4, G.5.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: BEGAN DISTAL CUT AND SAW LOOSENED OUT OF THE ATTACHMENT. TEC PUT THE SAW ON AGAIN AND TIGHTENED THE SAW DOWN WITH THE WRENCH. SAW LOOSENED OUT AGAIN IN CUTS, TEC RE-ATTACHED THE SAW WITH WRENCH AGAIN AND WE MADE IT THOUGH THE TWO ANGLED CUTS. DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING? YES/NO. AS PER THE MPS: YES. SAW ATTACHMENT COMPLETELY LOOSENED AND SAW FELL OUT AND THE SURGEON CAUGHT IT. THE SECOND TIME IT DID NOT FALL BECAUSE THE SURGEON ALREADY HAD A HAND ON THE BLADE. AFTER THE CASE WAS COMPLETED I TIGHTENED THE SAW TO SEE IF I COULD WIGGLE IT FREE AND IT FELT THAT THE FINAL CLICK TO TIGHTEN WAS NOT ENGAGING. ONCE GETTING THE SAW ATTACHMENT BACK FROM SPD TO SEND BACK FOR THE PER THE SAW ATTACHMENT WAS NOT CLICKING AT ALL WHEN TIGHTENING. 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: 01-05-2019. DEVICES MANUFACTURED: (B)(4). DEVICES FAILED INSPECTION: (B)(4). NC/NPR/QT NUMBERS: QT19-01-0013. 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: 35051218 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINTS RELATED TO P/N: 212480 WILL BE TRACKED BY TREND REQUEST# (B)(4). CONCLUSION: THE COMPLAINT OF THE SAW ATTACHMENT NOT CLAMPING THE BLADE PROPERLY WAS CONFIRMED. THE ISSUE WAS TRACED TO A STUCK RATCHETING PAWL. 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

    BEGAN DISTAL CUT AND SAW LOOSENED OUT OF THE ATTACHMENT. TEC PUT THE SAW ON AGAIN AND TIGHTENED THE SAW DOWN WITH THE WRENCH. SAW LOOSENED OUT AGAIN IN CUTS, TEC RE-ATTACHED THE SAW WITH WRENCH AGAIN AND WE MADE IT THOUGH THE TWO ANGLED CUTS. DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING? YES/NO. AS PER THE MPS: YES. SAW ATTACHMENT COMPLETELY LOOSENED AND SAW FELL OUT AND THE SURGEON CAUGHT IT. THE SECOND TIME IT DID NOT FALL BECAUSE THE SURGEON ALREADY HAD A HAND ON THE BLADE. AFTER THE CASE WAS COMPLETED I TIGHTENED THE SAW TO SEE IF I COULD WIGGLE IT FREE AND IT FELT THAT THE FINAL CLICK TO TIGHTEN WAS NOT ENGAGING. ONCE GETTING THE SAW ATTACHMENT BACK FROM SPD TO SEND BACK FOR THE PER THE SAW ATTACHMENT WAS NOT CLICKING AT ALL WHEN TIGHTENING.

    Description of Event or Problem · 0

    BEGAN DISTAL CUT AND SAW LOOSENED OUT OF THE ATTACHMENT. TEC PUT THE SAW ON AGAIN AND TIGHTENED THE SAW DOWN WITH THE WRENCH. SAW LOOSENED OUT AGAIN IN CUTS, TEC RE-ATTACHED THE SAW WITH WRENCH AGAIN AND WE MADE IT THOUGH THE TWO ANGLED CUTS. DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING? YES/NO. AS PER THE MPS: YES. SAW ATTACHMENT COMPLETELY LOOSENED AND SAW FELL OUT AND THE SURGEON CAUGHT IT. THE SECOND TIME IT DID NOT FALL BECAUSE THE SURGEON ALREADY HAD A HAND ON THE BLADE. AFTER THE CASE WAS COMPLETED I TIGHTENED THE SAW TO SEE IF I COULD WIGGLE IT FREE AND IT FELT THAT THE FINAL CLICK TO TIGHTEN WAS NOT ENGAGING. ONCE GETTING THE SAW ATTACHMENT BACK FROM SPD TO SEND BACK FOR THE PER THE SAW ATTACHMENT WAS NOT CLICKING AT ALL WHEN TIGHTENING.

    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

    BEGAN DISTAL CUT AND SAW LOOSENED OUT OF THE ATTACHMENT. TEC PUT THE SAW ON AGAIN AND TIGHTENED THE SAW DOWN WITH THE WRENCH. SAW LOOSENED OUT AGAIN IN CUTS, TEC RE-ATTACHED THE SAW WITH WRENCH AGAIN AND WE MADE IT THOUGH THE TWO ANGLED CUTS. DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING? YES/NO. AS PER THE MPS: YES. SAW ATTACHMENT COMPLETELY LOOSENED AND SAW FELL OUT AND THE SURGEON CAUGHT IT. THE SECOND TIME IT DID NOT FALL BECAUSE THE SURGEON ALREADY HAD A HAND ON THE BLADE. AFTER THE CASE WAS COMPLETED I TIGHTENED THE SAW TO SEE IF I COULD WIGGLE IT FREE AND IT FELT THAT THE FINAL CLICK TO TIGHTEN WAS NOT ENGAGING. ONCE GETTING THE SAW ATTACHMENT BACK FROM SPD TO SEND BACK FOR THE PER THE SAW ATTACHMENT WAS NOT CLICKING AT ALL WHEN TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184891 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35051218/3504926 00848486032128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization