BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CANNULATED

    MDR report key: 11851847 · Received May 19, 2021

    Report

    Report Number
    2939274-2021-02442
    Event Type
    Injury
    Date Received
    May 19, 2021
    Report Date
    April 21, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CANNULATED SCREW/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A PATIENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 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 · 1

    IT WAS REPORTED THAT IN (B)(6) 2000 THE PATIENT UNDERWENT A FOOT SURGERY. THE PATIENT IS INQUIRING ABOUT THE COMPOSITION OF THE PINS AND SCREWS THAT WERE USED DUE TO A SEVERE NICKEL ALLERGY AND POSSIBLE OTHER RELATED HEALTH ISSUES. THE PATIENT WAS IMPLANTED WITH THE FOLLOWING SCREWS: DEPUY GUIDE PIN FOR THE ACE 6.5 MM CANNULATED SCREW SET WITH 22 MM THREAD/ ACE PARTIALLY THREADED 6.5 MM CANNULATED TITANIUM CANCELLAS SCREW 14196-65/42309/65 MM. DEPUY 5 MM ACE GUIDE PINS/2 FULLY THREADED 5 MM ACE TITANIUM CANNULATED CANCELLAS LAG SCREWS 20 MM THREAD C-393-36/36 MM. THIS REPORT IS FOR ONE (1) UNKNOWN CANNULATED SCREW. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746720 UNK - SCREWS: CANNULATED SCREW,FIXATION,BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention