BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 8160724 · Received December 13, 2018

    Report

    Report Number
    3005985723-2018-00740
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 21, 2018
    Report Date
    February 18, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: STRAIGHT SAW ATTACHMENT WOULD NOT TIGHTEN. SURGICAL DELAY 16-30 MINUTES. PATIENT WAS UNDER ANESTHESIA. IT WAS DURING BONE PREP. CASE TYPE: (B)(4). FUNCTIONAL INSPECTION: SHOWS THAT THE ATTACHMENT KNOB WHEN TURNED DOES NOT MOVE THE BLADE CLAMP. THE FAILURE MODE IS CONFIRMED. VISUAL INSPECTION: VISUAL INSPECTION SHOWS NORMAL WEAR AND TEAR DAMAGE TO THE EXTERIOR OF THE PART AS WELL AS THE CAP PIN IS BROKEN AND THE RATCHETING HUB IS DEFORMED. SEE ATTACHED PICTURE. THE INSPECTION ALSO SHOWS WEAR MARKS ON THE KNOB FROM WHERE THE KNOB WRENCH MAKES CONTACT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE ITEM HAS BEEN USED AND THE DIMENSIONS AND TOLERANCES ON THE PRINT ARE NO LONGER AN ACCURATE REPRESENTATION OF THE PART. MATERIAL ANALYSIS: NOT PERFORMED AS THE FAILURE IS CONSISTENT WITH EXCESSIVE FORCE APPLIED TO 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: 05/19/2017. DEVICES MANUFACTURED: (B)(4). DEVICES FAILED INSPECTION: 5. NC/NPR/QT NUMBERS: QT17-05-0077. 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: 35010417/3501234 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINTS RELATED TO P/N: 212186 WILL BE TRACKED BY TREND REQUEST# 1191. CONCLUSION: THE COMPLAINT OF THE SAW ATTACHMENT NOT CLAMPING THE BLADE PROPERLY WAS CONFIRMED. THE ISSUE WAS TRACED TO A CAP PIN IS BROKEN AND THE RATCHETING HUB IS DEFORMED. THE ISSUE WAS OBSERVED DURING THE CASE AND RESULTED IN A 16-30 MINUTE DELAY, THERE WAS NO FURTHER HARM TO THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATES THERE IS NO NC OR CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    STRAIGHT SAW ATTACHMENT WOULD NOT TIGHTEN. SURGICAL DELAY 16-30 MINUTES PATIENT WAS UNDER ANESTHESIA IT WAS DURING BONE PREP. CASE TYPE: (B)(4).

    Additional Manufacturer Narrative · 1

    AS PART OF 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

    STRAIGHT SAW ATTACHMENT WOULD NOT TIGHTEN. SURGICAL DELAY16-30 MINUTES PATIENT WAS UNDER ANESTHESIA IT WAS DURING BONE PREP. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999916 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35010417/3501234 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization