BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECKPOINT, 3.5 HEX IMPACTION STERILE

    MDR report key: 8593688 · Received May 8, 2019

    Report

    Report Number
    3005985723-2019-00350
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 24, 2019
    Report Date
    September 29, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486017316
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT AS DR. NAWABI BEGAN TO REMOVE THE PELVIC CHECKPOINT AFTER CUP IMPACTION AND BEFORE BROACHING. AS HE PULLED THE HEX IMPACTION OUT WITH A RONGEUR, THE SHARP TIP BROKE OFF IN THE PATIENT. HE HAD TO USE A MIDIS TO GET IT OUT. PRODUCT EVALUATION AND RESULTS: AS PER ATTACHED PICTURE THE ALLEGED FAILURE MODE WAS CONFIRMED AS THE PROVIDED PICTURE SHOWS THAT THE DEVICE WAS BROKEN. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 1600 DEVICES WERE MANUFACTURED UNDER LOT NO W60750-1 AND ACCEPTED INTO FINAL STOCK ON 10/31/2018 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 111653, LOT W60750-1 SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. PR: 2052434 & 2109312. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED AS THE PROVIDED PICTURE SHOWS THAT THE DEVICE WAS BROKEN. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    (B)(6) BEGAN TO REMOVE THE PELVIC CHECKPOINT AFTER CUP IMPACTION AND BEFORE BROACHING. AS HE PULLED THE HEX IMPACTION OUT WITH A RONGEUR, THE SHARP TIP BROKE OFF IN THE PATIENT. HE HAD TO USE A MIDIS TO GET IT OUT. CASE TYPE: THA. SURGICAL DELAY: 16-30 MINUTES. UPDATE: "THERE WAS NO DEBRIS LEFT. NO MISSING OR DISASSEMBLE COMPONENTS OF THE DEVICE. (B)(6) BELIEVES IT WAS THE SHARP END OF HIS LARGE RONGEUR THAT BROKE THE HEX IMPACTION. HE WILL BE USING A DIFFERENT DEVICE TO REMOVE THE CHECKPOINT IN THE FUTURE."

    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

    DR. (B)(6) BEGAN TO REMOVE THE PELVIC CHECKPOINT AFTER CUP IMPACTION AND BEFORE BROACHING. AS HE PULLED THE HEX IMPACTION OUT WITH A RONGEUR, THE SHARP TIP BROKE OFF IN THE PATIENT. HE HAD TO USE A MIDIS TO GET IT OUT. CASE TYPE: THA. SURGICAL DELAY: 16-30 MINUTES. UPDATE: "THERE WAS NO DEBRIS LEFT. NO MISSING OR DISASSEMBLE COMPONENTS OF THE DEVICE. DR. (B)(6) BELIEVES IT WAS THE SHARP END OF HIS LARGE RONGEUR THAT BROKE THE HEX IMPACTION. HE WILL BE USING A DIFFERENT DEVICE TO REMOVE THE CHECKPOINT IN THE FUTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385491 CHECKPOINT, 3.5 HEX IMPACTION STERILE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W60750-1 00848486017316

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization