BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUT Ø14

    MDR report key: 17162091 · Received June 20, 2023

    Report

    Report Number
    8030965-2023-07682
    Event Type
    Injury
    Date Received
    June 20, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07612334168030
    PMA / PMN Number
    K201346
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H10 ADDITIONAL NARRATIVE: D2B: ADDITIONAL PRODUCT CODE: HSB. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J EMPLOYEE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PRODUCT CODE#:04.045.781S. LOT #:3098P53. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 05/12/2022. MANUFACTURING SITE: JABIL GRENCHEN. EXPIRY DATE:01/11/2032. THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE PROVIDED SERIES OF X-RAYS REVEALED THAT THERE WAS A NAIL AND SCREW CONSTRUCT IMPLANTED AT THE RIGHT TIBIA. IT WAS OBSERVED THAT THE NUT, PREVIOUSLY ASSEMBLED TO THE DISTAL LOCKING SCREW IN QUESTION, APPEARS TO HAVE GOTTEN LOOSE AT SOME POINT AND MIGRATED FROM THE POSITION IT WAS FIRST IMPLANTED. BASED ON THE PROVIDED EVIDENCE, THE INVESTIGATION WAS ABLE TO CONFIRM THE ALLEGATION OF LOOSE. NO OTHER PROBLEM IDENTIFIED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR NUT Ø14, P/N: 04.045.781S, LOT: 3098P53. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL DIAPHYSEAL FRACTURE WITH RFNA NAIL, NUT AND ANS LOCKING SCREWS. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023, BECAUSE THE SECOND SCREW HAD COME LOOSE, AND THE MOST DISTAL CONDYLAR NUT WAS ALSO LOOSE. THEREFORE, THE SECOND SCREW WAS REMOVED FROM THE DISTAL END AND THE MOST DISTAL CONDYLAR NUT WAS RETIGHTENED AND SUCCESSFULLY COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (B)(4). THIS IS REPORT 2 OF 2 FOR COMPLAINT. NUT Ø14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528049 NUT Ø14 SCREW, FIXATION, BONE HWC SYNTHES GMBH 3098P53 07612334168030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention LOCKSCR F/NAILS Ø5 L70 XL25| LOCKSCR F/NAILS Ø5 L70 XL25| RETROGRADE FEM NAIL ADVANCED Ø11 L300 5°