BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING: CALCANEAL

    MDR report key: 19850722 · Received July 29, 2024

    Report

    Report Number
    8030965-2024-09377
    Event Type
    Injury
    Date Received
    July 29, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    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. H11: ADDITIONAL NARRATIVE: A COPY OF THE LITERATURE ARTICLE CAN BE ACCESSED BY PASTING THE DOI IN AN INTERNET BROWSER WINDOW: HTTPS://DOI.ORG/10.1016/J.INJURY.2023.110921 B3: EXACT DATE OF EVENT IS UNKNOWN; LITERATURE ARTICLE WAS PUBLISHED ON JUNE 29, 2023. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: OU AND BAKER (2023), HINDFOOT NAILING FOR DISPLACED ANKLE FRACTURES IN THE ELDERLY: A CASE-CONTROL ANALYSIS, INJURY VOL. 54 (110921), PAGES 1-8 (NEW ZEALAND). DOI: HTTPS://DOI.ORG/10.1016/J.INJURY.2023.110921. BETWEEN JANUARY 1, 2010 TO DECEMBER 31, 2021, A TOTAL OF 52 PATIENTS (6 MALE AND 46 FEMALE) WITH A MEAN AGE OF 83.5 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS UNDERWENT HINDFOOT NAILING AND OPEN REDUCTION AND INTERNAL FIXATION (ORIF). 26 PATIENTS (3 MALE AND 23 FEMALE) WITH A MEAN AGE OF 84 YEARS WERE IDENTIFIED IN THE HINDFOOT GROUP USING VALOR HINDFOOT FUSION NAIL (WRIGHT MEDICAL) AND EXPERT HINDFOOT ARTHRODESIS NAIL (DEPUY SYNTHES) FOR MOST PATIENTS, AND A TRIGEN HINDFOOT FUSION NAIL (SMITH & NEPHEW) FOR THE REMAINING 2 PATIENTS; MATCHED TO 26 PATIENTS (3 MALE AND 23 FEMALE) WITH A MEAN AGE OF 83 YEARS IN THE ORIF GROUP. BOTH GROUP HAD A ROUTINE FOLLOW-UP CONSISTING OF CLINICAL AND RADIOGRAPHIC REVIEW AT TWO WEEKS, SIX WEEKS AND THREE MONTHS POST-OPERATIVELY. THIS REPORT COVERS FOUR (4) PATIENTS WITH METALWARE FAILURE DUE TO THE CALCANEAL SCREW BACKING OUT AND CAUSING PAIN AND/OR SKIN COMPROMISE REQUIRING REOPERATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES EXPERT HINDFOOT ARTHRODESIS NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950962 UNK - SCREWS: LOCKING: CALCANEAL SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention