BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9512808 · Received December 23, 2019

    Report

    Report Number
    0002249697-2019-04089
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    November 29, 2019
    Report Date
    February 25, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    07613327412376
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: TWO OF THE 3.2MM X 140MM BONE PINS SNAPPED OFF INSIDE PATIENT WHILE DRILLING. APPROX. 1CM OF THE THREADED PART OF THE PIN SNAPPED OFF THE FIRST, APPROXIMATELY 4MM OF THE SECOND. FIRST PIN SNAPPED ON I SECTION, 2ND SNAPPED ON EXTRACTION. CASE TYPE: TKA. 16-30 MINUTES. PRODUCT EVALUATION: 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 48470618, SHOWS 00 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE EVENT COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR INSPECTION. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    TWO OF THE 3.2MM X 140MM BONE PINS SNAPPED OFF INSIDE PATIENT WHILE DRILLING. APPROX. 1CM OF THE THREADED PART OF THE PIN SNAPPED OFF THE FIRST, APPROXIMATELY 4MM OF THE SECOND. FIRST PIN SNAPPED ON I SECTION, 2ND SNAPPED ON EXTRACTION. CASE TYPE: TKA. 16-30 MINUTES.

    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

    TWO OF THE 3.2MM X 140MM BONE PINS SNAPPED OFF INSIDE PATIENT WHILE DRILLING. APPROX. 1CM OF THE THREADED PART OF THE PIN SNAPPED OFF THE FIRST, APPROXIMATELY 4MM OF THE SECOND. FIRST PIN SNAPPED ON I SECTION, 2ND SNAPPED ON EXTRACTION. CASE TYPE: TKA. 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303897 BONE PIN, 3.2MM X 140MM, STERILE 2 PACK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 213527 48470618 07613327412376

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other