BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE MICS

    MDR report key: 19257882 · Received May 7, 2024

    Report

    Report Number
    3005985723-2024-00056
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 15, 2024
    Report Date
    October 28, 2024
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K172219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISASSOCIATION INVOLVING A MAKO MICS WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: PIVOT MECHANISM - MISSING SCREWS. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER COMPLAINTS WITH SIMILAR EVENT(S) FOR THE LOT REFERENCED. (DISASSOCIATION). CONCLUSIONS: THE ALLEGED FAILURE OF THE DEVICE WAS CONFIRMED THROUGH PRODUCT INSPECTION. ALTHOUGH THE HARM TO THE PATIENT WAS NOT CONFIRMED (NO MEDICAL RECORDS WERE PROVIDED), THE MPS DID STATE THAT THE PATELLA TENDON WAS CUT IN THE COMPLAINT EVENT DETAILS. A REVIEW OF DOCUMENT "MAKO TKA 2.0 SURGICAL GUIDE", HAS IDENTIFIED THE FOLLOWING PERTINENT INFORMATION: IT IS STATED: "MANAGEMENT OF THE PATELLA, REMOVAL OF THE FAT PAD, AND ASSOCIATED RETRACTOR PLACEMENT IS BASED ON SURGEON PREFERENCE." THE DOCUMENT PROVIDES THAT: "THE STEREOTACTIC BOUNDARY USED TO CONSTRAIN THE SAW BLADE IS GENERATED BASED ON THE IMPLANT SIZE, SHAPE, AND PLAN. THE MAKO ROBOTIC-ARM DOES NOT HAVE THE ABILITY TO TRACK THE PATIENT'S SOFT TISSUE STRUCTURES. IT IS RECOMMENDED TO USE STANDARD RETRACTION TECHNIQUES DURING CUTTING." ADDITIONALLY, STEPS OUTLINING HOW TO PLACE RETRACTORS TO SAFEGUARD THE PATELLAR TENDON ARE DETAILED. FINALLY, IT IS NOTED: "STEREOTACTIC BOUNDARIES HELP PROTECT THE CUTTING TOOL FROM INJURING SOFT TISSUES; HOWEVER, PATIENT ANATOMY, IMPLANT PLAN, AND SURGEON-SPECIFIC TECHNIQUES VARY. THE SURGEON IS RESPONSIBLE FOR PROPERLY RETRACTING SOFT TISSUES DURING BONE RESECTION, INCLUDING BUT NOT LIMITED TO: COLLATERAL LIGAMENTS, PATELLAR TENDON, QUADRICEPS MECHANISM, AND PCL." THE ULTIMATE RESPONSIBILITY FOR ENSURING PATIENT SAFETY AND THE INTEGRITY OF THE PATELLAR TENDON RESTS WITH THE SURGEON. HAD THE RETRACTOR BEEN APPROPRIATELY POSITIONED DURING THE PROCEDURE, IT WOULD HAVE EFFECTIVELY SHIELDED THE PATELLAR TENDON FROM UNDUE STRESS OR INADVERTENT INJURY. AS A RESULT, THE PATELLAR TENDON WAS INADVERTENTLY PARTIALLY CUT WHEN THE SURGEON WAS CUTTING LATERALLY. A SURGEON MUST ALWAYS RELY ON HIS OR HER OWN PROFESSIONAL CLINICAL JUDGMENT WHEN DECIDING WHETHER TO USE A PARTICULAR PRODUCT WHEN TREATING A PARTICULAR PATIENT. STRYKER DOES NOT DISPENSE MEDICAL ADVICE AND RECOMMENDS THAT SURGEONS BE TRAINED IN THE USE OF ANY PARTICULAR PRODUCT BEFORE USING IT IN SURGERY. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    DR. (B)(6) ROTATED THE SAW HANDLE TO THE 3 O CLOCK POSITION. WHILE CUTTING LATERALLY, THE SAW POPPED OUT OF THE LOCKED POSITION AND ENDED UP CAUSING HARM TO THE PATIENT. THE PATIENT'S PATELLA TENDON WAS PARTIALLY CUT BY THE SAW. DR. (B)(6) WAS ABLE TO FINISH THE HIS CUTS, TRIAL, THEN PUT IN FINAL IMPLANTS. HE USED #1 ETHIBONS TO REPAIR THE PATELLA TENDON. FROM WHAT I SAW, IT LOOKED LIKE A NICE STABLE REPAIR. CASE TYPE / APPLICATION: TKA 2.0.

    Description of Event or Problem · 0

    DR. (B)(6) ROTATED THE SAW HANDLE TO THE 3 O CLOCK POSITION. WHILE CUTTING LATERALLY, THE SAW POPPED OUT OF THE LOCKED POSITION AND ENDED UP CAUSING HARM TO THE PATIENT. THE PATIENT'S PATELLA TENDON WAS PARTIALLY CUT BY THE SAW. DR. (B)(6) WAS ABLE TO FINISH THE HIS CUTS, TRIAL, THEN PUT IN FINAL IMPLANTS. HE USED #1 ETHIBONS TO REPAIR THE PATELLA TENDON. FROM WHAT I SAW, IT LOOKED LIKE A NICE STABLE REPAIR. CASE TYPE / APPLICATION: TKA 2.0. UPDATE 18/APRIL/2024 (B)(6): SPOKE TO (B)(6): LEFT MAKO TKA 2.0. THE MICS HANDLE WAS ROTATED TO THE 3 O'CLOCK POSITION. WHEN IN HAPTICS, THE MICS HANDLE UNLOCKED FROM THE 3 O'CLOCK POSITION. THIS JARRED THE SURGEON'S HAND, WHICH LED TO THE PATIENT'S TENDON BEING CUT (SURGEON REPORTED 60% OF THE TENDON WAS CUT). THE SAW HAD REMAINED LOCKED TO THE MICS - IT WAS THE FAILURE OF THE ROTATION LOCK OF THE MICS WHICH CAUSED THE JARRING OF THE SURGEON'S HAND AND THE CUT OF THE TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669624 HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 42060718 / 4204559 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R