BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM F/IM NAIL-STER

    MDR report key: 5846685 · Received August 4, 2016

    Report

    Report Number
    3000270450-2016-10189
    Event Type
    Injury
    Date Received
    August 4, 2016
    Report Date
    July 20, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. EXACT DATE OF SYMPTOM ONSET IS UNKNOWN. (B)(4). THE COMPLAINANT PARTS HAVE NOT BEEN EXPLANTED AT THIS PRESENT TIME. THE COMPLAINANT PARTS ARE NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: MARCH 11, 2014- EXPIRY DATE: MARCH 1, 2024. NO NON-CONFORMANCE REPORTS (NCR) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. AS THE ISSUE WAS NOT RELATED TO STERILIZATION, A REVIEW OF THE NON-STERILE DHR WAS CONDUCTED AS WELL. RESULTS ARE AS FOLLOWS: NON-STERILE: 04.005.516 / 8792511. MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JANUARY 7, 2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PRODUCT WAS NOT RECEIVED FOR ACTUAL EVALUATION, A REVIEW OF THE MATERIAL WAS CONDUCTED BASED UPON THE ALLEGED ALLERGIC REACTION EXPERIENCED BY THE PATIENT. ALL OF THE SPECIFIED ARTICLES MENTIONED WERE MANUFACTURED FROM A TITANIUM ALLOY MATERIAL (TI AL6 NB7). THE INTERNATIONAL STANDARDS GOVERNING USE OF THIS MATERIAL SPECIFIES THAT THE CHARACTERISTICS OF AND CORRESPONDING TEST METHODS FOR THE WROUGHT TITANIUM ALLOY (KNOWN AS TITANIUM 6-ALUMINIUM 7-NIOBIUM ALLOY (TITANIUM 6-AI 7-NB)) BE CONFORMING WHEN USED TO MANUFACTURE SURGICAL IMPLANTS. NO KNOWN SURGICAL IMPLANT MATERIAL HAS EVER BEEN SHOWN TO BE COMPLETELY FREE OF ADVERSE REACTIONS IN THE HUMAN BODY. HOWEVER, LONG-TERM CLINICAL EXPERIENCE OF THE USE OF THIS MATERIAL HAS SHOWN THAT AN ACCEPTABLE LEVEL OF BIOLOGICAL RESPONSE CAN BE EXPECTED WHEN THE MATERIAL IS USED IN APPROPRIATE APPLICATIONS. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A SUBTALAR ARTHRODESIS (RIGHT) PROCEDURE ON (B)(6) 2012 TO TREAT A DIAGNOSIS OF DESTRUCTIVE SUBTALAR ARTHROSIS. DURING THE PROCEDURE, THE PATIENT WAS IMPLANTED WITH A HINDFOOT ARTHRODESIS NAIL, AN EXPERT END CAP, A CANNULATED SCREW, AND FOUR (4) LOCKING SCREWS. ADDITIONALLY, THE SURGEON FILLED WITH HOMOLOGOUS CANCELLOUS BONE TO COMPLETE THE SYNOVECTOMY. ON AN UNKNOWN POST-OPERATIVE DATE, IT WAS NOTED THAT THE PATIENT HAD DEVELOPED AN ALLERGIC REACTION. THERE HAVE BEEN NO PLANS MADE AT THIS TIME TO REMOVE THE HARDWARE; HOWEVER, A REQUEST HAS BEEN MADE FOR MATERIAL SAMPLES IN ORDER TO CONDUCT ALLERGY TESTING. THIS REPORT IS 2 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499508 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM F/IM NAIL-STER SCREW, FIXATION, BONE HWC SYNTHES SELZACH 8878293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention