BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN, 3.2MM X 140MM, STERILE 2 PACK

    MDR report key: 6667190 · Received June 26, 2017

    Report

    Report Number
    3005985723-2017-00270
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    June 8, 2017
    Report Date
    August 31, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE, 3.2MM X 140MM BONE PIN, BROKE DURING INSERTION FOR THE ARRAY PLACEMENT. THE BONE WAS PREDRILLED WITH A Ø2.0MM DRILL. THE TIP OF THE BONE PIN REMAINS IN THE PATIENT. A SURGICAL DELAY OF 20 MINUTES WAS COMMUNICATED. VISUAL INSPECTION: VISUAL INSPECTION SHOWS THE PIN SHAFT SHEARED OFF APPROXIMATELY 46MM FROM THE START OF THE THREADED SECTION. SEE ATTACHED IMAGES. DIMENSIONAL INSPECTION: THE THREAD MAJOR DIAMETER WAS MEASURED ON THE REMAINING 46MM OF THE PIN SHAFT USING A CALIPER, TN0081-10 (CALIBRATION DUE 31 JULY 2018). THE MEASUREMENT WAS Ø3.21MM WHICH IS WITHIN THE Ø3.2±0.05MM TOLERANCE PER DRAWING 143000 REV 00. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY FOR THE ASSOCIATED LOT INDICATED 862 DEVICES (NON-STERILE P/N 143000-07 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED AND ACCEPTED ON JUNE 10TH, 2016. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN STRYKER'S DATABASE RELATED TO P/N 143140, LOT NUMBER W46874 SHOWS 1 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THIS COMPLAINT INVESTIGATION IS PR (B)(4). CONCLUSIONS: THE FAILURE WAS CONFIRMED WITH THE EVALUATION OF THE RETURNED DEVICE. A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN TWO CAPAS ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. ONE CAPA HAS BEEN COMPLETED (CATSWEB SYSTEM IS CAPA (B)(4)) WHILE THE SECOND IS STILL OPEN (TRACKWISE (B)(4)). 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 · 1

    MULTIPLE PINS BROKEN DURING INSERTION FOR THE ARRAY PLACEMENT. SURGEON PREDRILLED WITH A 2.0 DRILL BEFORE PLACING

    Description of Event or Problem · 1

    MULTIPLE PINS BROKEN DURING INSERTION FOR THE ARRAY PLACEMENT. SURGEON PRE-DRILLED WITH A 2.0 DRILL BEFORE PLACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449220 BONE PIN, 3.2MM X 140MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W46874ROB238

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other