BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 13481227 · Received February 8, 2022

    Report

    Report Number
    2939274-2022-00389
    Event Type
    Injury
    Date Received
    February 8, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982095701
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PART # 04.037.012S, SYNTHES LOT # H812702, SUPPLIER LOT # N/A, RELEASE TO WAREHOUSE DATE: 17 JAN 2019, EXPIRATION DATE: 31 DEC 2028, MANUFACTURING LOCATION: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO PAIN. THERE WAS NO BROKEN IMPLANT REPORTED. THE SURGEON THEN CONVERTED PATIENT TO A TOTAL HIP ARTHROPLASTY. REMOVED HARDWARE SUCCESSFULLY. PATIENT CONSEQUENCE UNKNOWN. THIS REPORT IS FOR ONE (1) 10MM/125 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596049 10MM/125 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.012S H812702 10886982095701

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention 5.0 TI LOCKING SCREW 32- FOR IM NAILS| TFNA FENESTRATED HELICAL BLADE 85 - SILE