BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 16584734 · Received March 21, 2023

    Report

    Report Number
    8030965-2023-03488
    Event Type
    Injury
    Date Received
    March 21, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THIS REPORT IS FOR AN UNK - SCREWS: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: REPORTER IS A J&J EMPLOYEE. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 · 0

    AN ADVERSE EVENT HAS BEEN REPORTED ON AN UNKNOWN DATE IN THE DATABASE FOR CRFS FOR THE CLINICAL STUDY DST202103 SUBJECT 0073-019. ADVERSE EVENT: NONUNION, START DATE: (B)(6) 2023, TYPE OF EVENT: LOCAL/FRACTURE SITE, CREATION DATE: (B)(6) 2023, SEVERITY: MODERATE. THIS REPORT IS FOR ONE (1) UNK - SCREWS: TRAUMA. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25066 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention RFNA/ 10MM/ 360MM/ STANDARD BEND/ STER.| UNK - SCREWS: TRAUMA.