BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: NAIL DISTAL LOCKING

    MDR report key: 14078496 · Received April 11, 2022

    Report

    Report Number
    8030965-2022-02364
    Event Type
    Injury
    Date Received
    April 11, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. PATIENT HEIGHT REPORTED AS 186CM. PATIENT¿S DATE OF BIRTH IS AN UNKNOWN DATE IN 1979. THIS REPORT IS FOR AN UNKNOWN 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. 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 · 0

    THE SITE MUE (B)(4) REPORTED TWO ADVERSE EVENTS IN OUR DATABASE WHICH IS CONSIDERED (POSSIBLY) RELATED TO THE DEVICE. SUBJECT MUE-010. POSTOPERATIVE ADVERSE EVENT: SOFT TISSUE WOUND LOWER LEG; THE EPIGARD AND THE DERMOTRACTION STILL SECRETE BLOODY IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? YES IS THE AE RELATED TO THE DEVICE? YES. DPS IMPLANT WAS USED. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 5 OF 5 FOR PC-:(B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER PC: (B)(4).

    Description of Event or Problem · 0

    THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THIS REPORT IS A DUPLICATE REPORT. EVENT WAS CAPTURED ON COMPLAINT (B)(4), MEDWATCH REPORT 8030965-2022-02113.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211346 UNK - SCREWS: NAIL DISTAL LOCKING SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention EXPERT TIBIAL NAIL PROTECT Ø11 CANN L375.| UNK - SCREWS: NAIL LOCKING.