BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9260623 · Received October 31, 2019

    Report

    Report Number
    3005985723-2019-00789
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 7, 2019
    Report Date
    February 13, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    07613327412376
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: 3.2 X 140 PIN BROKE IN HALF WHEN DR. WAS REMOVING THE PIN. CASE TYPE: TKA. PRODUCT INSPECTION: PRODUCT INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY : REVIEW PRODUCT HISTORY REVIEW DID NOT REVEAL ANY RESULTS AND PRODUCT WAS NOT RETURNED. COMPLAINT HISTORY: REVIEW A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 213527, LOT NUMBER 48940618 SHOWS 00 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION N. CONCLUSION: THE EVENT COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR INSPECTION. NC/CAPA HISTORY REVIEW: CORRECTIVE ACTION/PREV ENTIVE 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    3.2 X 140 PIN BROKE IN HALF WHEN DR. WAS REMOVING THE PIN. CASE TYPE: TKA. UPDATE: PIN WAS BEING REMOVED FROM FEMUR WHEN IT BROKE. IT WAS IN THE FEMORAL ARRAY STABILIZER. BOTH HALVES OF BONE PIN REMOVED.

    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

    3.2 X 140 PIN BROKE IN HALF WHEN DR. WAS REMOVING THE PIN. CASE TYPE: TKA. UPDATE: PIN WAS BEING REMOVED FROM FEMUR WHEN IT BROKE. IT WAS IN THE FEMORAL ARRAY STABILIZER. BOTH HALVES OF BONE PIN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055089 BONE PIN, 3.2MM X 140MM, STERILE 2 PACK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 213527 UNKNOWN 07613327412376

    Patients

    Seq Age Sex Outcome Treatment
    1 Other