BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL NAIL, STANDARD T2 TIBIA Ø10X345 MM

    MDR report key: 5989914 · Received September 30, 2016

    Report

    Report Number
    0009610622-2016-00462
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    September 9, 2016
    Report Date
    January 17, 2017
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TWO EVENTS: A T2 TIBIA NAIL WAS EXPLANTED DUE TO AN INFECTION AND DURING THE EXPLANTATION THE THREAD OF THE UNIVERSAL ROD GOT DAMAGED. THE EVALUATION REVEALED THE NAIL AND UNIVERSAL ROD TO BE PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE PRODUCTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. REGARDING EXPLANTED NAIL DUE TO INFECTION: THE CHECKLIST FOR THE CUSTOMER, DQF 13-003 ¿INFECTION COMPLAINTS - CHECKLIST CUSTOMER¿, WAS PROVIDED TO THE CUSTOMER WITHOUT SUCCESS. THE INFECTION CAUSING GERM AND CIRCUMSTANCES ARE UNKNOWN. AN EXTENDED INVESTIGATION WAS PERFORMED ACCORDING TO DQF 13-002 ¿INFECTION COMPLAINTS - CHECKLIST INVESTIGATOR¿. NO DEVIATIONS WERE FOUND; THE NAIL WAS PACKED, STERILIZED AND STORED WITHIN SPECIFICATIONS. DECONTAMINATION DURING MANUFACTURING CAN BE EXCLUDED. THEREFORE THE INFECTION WAS MOST LIKELY CAUSED BY THE HOSPITAL OR THE PATIENT. THE IFU ADDRESSES THAT ALL STERILE IMPLANTS AND INSTRUMENTS MUST BE CHECKED PRIOR SURGERY REGARDING DEFECTIVE STERILE BARRIERS; IN CASE THE STERILITY IS UNCLEAR THE PRODUCTS HAVE TO BE DECONTAMINATED / STERILIZED PRIOR TO THE SURGERY. THE IFU CONTAINS RECOMMENDED STERILIZATION METHODS. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY DISCREPANCIES. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT(S). NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NAIL WAS REMOVED DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NAIL WAS REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641389 TIBIAL NAIL, STANDARD T2 TIBIA Ø10X345 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K06DCBC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention