BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM

    MDR report key: 8010638 · Received October 26, 2018

    Report

    Report Number
    0009610622-2018-01365
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    September 28, 2018
    Report Date
    February 15, 2019
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540197795
    PMA / PMN Number
    K003018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ITEMS WERE NOT RETURNED TO STRYKER (¿HOSPITAL POLICY¿). THE REVIEW OF THE PRODUCT HISTORY (INCLUDING THE STERILIZATION CERTIFICATE) OF THE REPORTED IMPLANTS REVEALED NO CONSPICUITY. NO DEVIATION WAS FOUND IN THE STERILIZATION AND PACKAGING PROCESSES. THE ITEMS WERE DOCUMENTED FAULTLESS PRIOR TO DISTRIBUTION. NO ADDITIONAL INFORMATION SUCH AS MEDICAL RECORDS, IMAGES OR SURGERY REPORTS WAS PROVIDED ALTHOUGH REPEATEDLY REQUESTED. THIS ALSO APPLIES TO THE QUESTIONNAIRE ¿DQF 13-003 INFECTION COMPLAINTS CHECKLIST CUSTOMER¿, WHICH WAS SENT OUT AS MANDATORY IN INFECTION CASES; THE (FILLED OUT) FORM WAS NOT RETURNED, BECAUSE OF PER HOSPITAL POLICY THEY DID NOT WANT TO RELEASE ANY INFORMATION OR FILL OUT THE FORM. LIKEWISE, NO FURTHER INFORMATION REGARDING THE KIND OF INFECTION (E.G. MICROBIOLOGICAL GERM-PROOF WITH RESISTOGRAM) WAS PROVIDED. WE HAVE RECEIVED NO INFORMATION REGARDING OTHER POTENTIAL SOURCES OF INFECTION, INCLUDING BUT NOT LIMITED TO THE PATIENT OR THE FACILITY. THERE WAS NO NC / CAPA FILED FOR THIS PRODUCT WITH THIS FAILURE MODE. BASED ON THE ABOVE ACCORDING REVIEW OF ¿DQF 13-002 INFECTION COMPLAINTS CHECKLIST INVESTIGATOR¿ REVEALED A DEFICIENCY OF THE REPORTED DEVICES COULD NOT BE VERIFIED. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES, RISK ANALYSIS AND THE LABELLING DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE EVENT FOR THE SUBJECT PRODUCTS. NO NON-CONFORMITY WAS IDENTIFIED. IN THE CASE OF A CLINICALLY MANIFEST INFECTION, IN WHICH ANY STERILE PACKED STRYKER DEVICE WAS INVOLVED, DQF 13-003 SHALL BE FILLED BY THE HOSPITAL (OR EXCEPTIONALLY BY THE SALES REP) DUE TO FORMAL REASONS. IF THERE ARE NO OBVIOUS EVENTS, WHICH MAY BE CAUSED IN THE FIELD OF RESPONSIBILITY OF STRYKER, STRYKER DECLINES ALL RESPONSIBILITY IN GENERAL BECAUSE THE PROBABILITY THAT A CONTAMINATION OF THE STERILE PACKED DEVICES HAS BEEN CAUSED IN STRYKER¿S SPHERE OF INFLUENCE IS NEGLIGIBLE. HOWEVER, BASED ON THE LIMITED INFORMATION GIVEN THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, AS WELL. IN CASE PRODUCT OR ESSENTIAL INFORMATION BECOMES AVAILABLE WE RESERVE THE RIGHTS TO RE-OPEN THE INVESTIGATION INCL. CHANGE OF ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT TIBIA WAS REVISED DUE TO SUSPICION OF INFECTION AFTER PATIENT PRESENTED WITH PUS AT THE IMPLANT SITE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT TIBIA WAS REVISED DUE TO SUSPICION OF INFECTION AFTER PATIENT PRESENTED WITH PUS AT THE IMPLANT SITE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849206 TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K0DC555 04546540197795

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention