BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8562784 · Received April 29, 2019

    Report

    Report Number
    3005985723-2019-00322
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 11, 2019
    Report Date
    June 27, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: UNABLE TO ATTACH/TIGHTEN SAW; CASE TYPE: TKA; DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING? YES/NO AS PER THE MPS: YES, THE BLADE FELL OUT. 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 THAT THE RATCHETING PAWL IS STUCK INSIDE THE RATCHETING HUB. SEE ATTACHED PICTURE. 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: 12-14-2017; DEVICES MANUFACTURED: (B)(4); DEVICES FAILED INSPECTION: 0; NC/NPR/QT NUMBERS: 0. PRODUCT HISTORY REVIEW SHOWS NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N: 212186, LOT NUMBER: 35031117 SHOWS 1 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT # (B)(4). COMPLAINTS RELATED TO P/N: 212186 WILL BE TRACKED BY TREND REQUEST# 1191. CONCLUSION: THE COMPLAINT OF THE SAW BLADE NOT STAYING CLAMPED WAS CONFIRMED. THE FAILURE WAS TRACED TO A STUCK RATCHETING PAWL IN THE LOCKING KNOB ASSEMBLY. 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

    UNABLE TO ATTACH/TIGHTEN SAW. CASE TYPE: TKA. DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING? YES/NO. AS PER THE MPS: YES, THE BLADE FELL OUT.

    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

    UNABLE TO ATTACH/TIGHTEN SAW. CASE TYPE: TKA. DID THE BLADE FALL OUT OF THE HANDPIECE DURING CUTTING (YES/NO)? AS PER THE MPS: YES, THE BLADE FELL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354671 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3502641 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization