BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN, 3.2MM X 80MM, STERILE 2 PACK

    MDR report key: 6443076 · Received March 29, 2017

    Report

    Report Number
    3005985723-2017-00154
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    March 27, 2017
    Report Date
    May 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE, 3.2MM X 80MM BONE PIN, WAS NOTICED TO HAVE FRACTURED WHEN REMOVING THE BONE PIN IN THE TIBIA AT THE END OF A PKA CASE. THIS BROKEN BONE PIN WAS FROM A REPLACEMENT SET OF PINS USED AFTER THE INITIAL SET BROKE DURING INITIAL SETUP. THE INVESTIGATION OF THE INITIAL PIN SET FAILURE USED AT THE BEGINNING OF THE CASE IS DOCUMENTED IN PI 1478386. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 143080, LOT NUMBER W44718 SHOWS 4 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: PR 1276687, 1303123, 1310503, 1348429 AND 1478387. CONCLUSIONS: THE FAILURE WAS CONFIRMED WITHOUT THE EVALUATION OF THE RETURNED DEVICE. A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAS BEEN ONE CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THE CAPA COMPLETED IN THE CATSWEB SYSTEM IS CAPA (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.

    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

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. DURING PLACEMENT OF THE PINS IN THE TIBIA, THE TIP OF THE 3.2 X80 PIN BROKE OFF INTO THE PTS BONE. REPLACEMENT PINS WERE OPENED AND THE SURGEON WAS ABLE TO PLACE THE PIN WITHOUT DIFFICULTY. HOWEVER IT WAS NOTED DURING REMOVAL OF THE PINS THAT THE TIP HAD BROKEN OFF A SECOND TIME.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. DURING PLACEMENT OF THE PINS IN THE TIBIA, THE TIP OF THE 3.2 X80 PIN BROKE OFF INTO THE PTS BONE. REPLACEMENT PINS WERE OPENED AND THE SURGEON WAS ABLE TO PLACE THE PIN WITHOUT DIFFICULTY. HOWEVER IT WAS NOTED DURING REMOVAL OF THE PINS THAT THE TIP HAD BROKEN OFF A SECOND TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226900 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W44720-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other