BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE ANGLED SAGITAL SAW

    MDR report key: 9166167 · Received October 8, 2019

    Report

    Report Number
    3005985723-2019-00725
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 30, 2019
    Report Date
    January 27, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032128
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT "DURING THE CUTTING OF THE DISTAL FEMUR, THE NARROW SAW BLADE FELL OUT OF THE ANGLED SAW ATTACHMENT. WE PUT THE BLADE BACK ON, TIGHTENED IT, RE-DID PROBE CHECK ON SAWBLADE FOR ACCURACY WHICH PASSED, THEN BEGAN CUTTING AGAIN. THE SAW BLADE BECAME UNTIGHTENED AND FELL OFF AGAIN DURING CUTS. AFTER THAT, WE REPLACED THE ANGLED SAW ATTACHMENT AND COMPLETED ALL CUTS. SURGICAL DELAY: YES <= 15 MINUTES." METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES 42 DEVICE(S) WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 02/06/2019 AND 08 DEVICE(S) WERE REJECTED. REVIEW OF QT19-02-0017 INDICATES THE FOLLOWING: 08 DEVICE(S) WITH S/N (B)(6), 3505474, 3505495, 3505477, 3505483, 3505506, 3505504, 3505475 WERE QUARANTINED DUE TO DIMENSIONAL DISCREPANCIES; A QUARANTINE DISPOSITION WAS NOT REPORTED. PRODUCT HISTORY REVIEW SHOWS THE NONCONFORMITY DID NOT CONTRIBUTE TO THE EVENT ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212480, LOT 35070119 SHOWS 01 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE INCLUDE THE FOLLOWING PR(S): (B)(4). COMPLAINTS RELATED TO P/N: 212480 WILL BE TRACKED BY TREND REQUEST #: (B)(4). CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE PRODUCT WAS NOT RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS OR INVESTIGATOR. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    DURING THE CUTTING OF THE DISTAL FEMUR, THE NARROW SAW BLADE FELL OUT OF THE ANGLED SAW ATTACHMENT. WE PUT THE BLADE BACK ON, TIGHTENED IT, RE-DID PROBE CHECK ON SAWBLADE FOR ACCURACY WHICH PASSED, THEN BEGAN CUTTING AGAIN. THE SAW BLADE BECAME UNTIGHTENED AND FELL OFF AGAIN DURING CUTS. AFTER THAT, WE REPLACED THE ANGLED SAW ATTACHMENT AND COMPLETED ALL CUTS. SURGICAL DELAY: YES <= 15 MINUTES. CASE TYPE: TKA.

    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

    DURING THE CUTTING OF THE DISTAL FEMUR, THE NARROW SAW BLADE FELL OUT OF THE ANGLED SAW ATTACHMENT. WE PUT THE BLADE BACK ON, TIGHTENED IT, RE-DID PROBE CHECK ON SAWBLADE FOR ACCURACY WHICH PASSED, THEN BEGAN CUTTING AGAIN. THE SAW BLADE BECAME UNTIGHTENED AND FELL OFF AGAIN DURING CUTS. AFTER THAT, WE REPLACED THE ANGLED SAW ATTACHMENT AND COMPLETED ALL CUTS. SURGICAL DELAY: YES, 15 MINUTES. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962544 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 212480 35070119 / 3505473 00848486032128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization