BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP 5.0MM CANNULA

    MDR report key: 4211807 · Received October 29, 2014

    Report

    Report Number
    0002936485-2014-00853
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: MATERIAL/DESIGN ERROR; MANUFACTURING/ASSEMBLY ERROR; INADEQUATE PACKAGE SEAL STRENGTH (PACKAGING DESIGN); IMPROPER CLEANING/STERILIZATION FOR REUSABLE DEVICES. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT HAD LEFT HIP ARTHROSCOPY FOR REPAIR OF LEFT FEMOROACETABULAR IMPINGEMENT AND LEFT HIP LABRAL BRUISING. THE PATIENT RETURNED FOR ROUTINE POST SURGICAL FOLLOW-UP ON (B)(6) 2014. IMAGING TAKEN DURING THE VISIT IDENTIFIED A "LINEAR RADIOPAQUE FOREIGN BODY OVERLIES THE LEFT SUPERIOR ACETABULUM EXTENDING TO OVERLIE THE SACRUM MEASURING JUST UNDER 14 CM IN LENGTH." THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2014 THE FOREIGN OBJECT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. AFTER REMOVAL THE OBJECT WAS INSPECTED AND FOUND TO BE A METAL HIP SCOPE CANNULA THAT HAD APPARENTLY UNKNOWINGLY SEPARATED FROM THE HUB/CONNECTOR DURING THE INITIAL SURGERY ON (B)(6) 2014.

    Description of Event or Problem · 1

    PATIENT HAD LEFT HIP ARTHROSCOPY FOR REPAIR OF LEFT FEMOROACETABULAR IMPINGEMENT AND LEFT HIP LABRAL BRUISING. THE PATIENT RETURNED FOR ROUTINE POST SURGICAL FOLLOW-UP ON (B)(6) 2014. IMAGING TAKEN DURING THE VISIT IDENTIFIED A "LINEAR RADIOPAQUE FOREIGN BODY OVERLIES THE LEFT SUPERIOR ACETABULUM EXTENDING TO OVERLIE THE SACRUM MEASURING JUST UNDER 14 CM IN LENGTH." THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2014 THE FOREIGN OBJECT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. AFTER REMOVAL THE OBJECT WAS INSPECTED AND FOUND TO BE A METAL HIP SCOPE CANNULA THAT HAD APPARENTLY UNKNOWINGLY SEPARATED FROM THE HUB/CONNECTOR DURING THE INITIAL SURGERY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691566 HIP 5.0MM CANNULA ACCESSORIES, ARTHROSCOPIC NBH STRYKER ENDOSCOPY-SAN JOSE 168818 (AS REPORTED)

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR