BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS O/T INTERLOCKING NAILS

    MDR report key: 18351075 · Received December 18, 2023

    Report

    Report Number
    9610612-2023-00272
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    September 8, 2020
    Report Date
    February 13, 2024
    Manufacturer
    AESCULAP AG
    Product Code
    NDH
    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

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT, THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. WE DO NOT HAVE ANY FURTHER INFORMATION AVAILABLE AT THIS TIME. A PRODUCT INVESTIGATION INCLUDING THE STATISTICAL ANALYSIS AND A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE. DEVICE HISTORY REVIEW: DUE TO THE FACT THAT THERE IS NEITHER A PRODUCT CODE NOR A LOT NUMBER, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON: - SERIOUS INJURY (REPORT NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON PATIENT HARM, DEATH. CONCLUSION/PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT AE-QAS-O559 (UNKNOWN ITEM CODE OF INTERLOCKING NAILS). ACCORDING TO THE COMPLAINT DESCRIPTION, ON (B)(6) 2020, THE PATIENT UNDERWENT NAIL REMOVAL SURGERY FOR A TARGON NAIL THAT HAD BEEN PLACED IN THE RIGHT FEMUR PREVIOUSLY. DURING REMOVAL, THE RIGHT SUPERIOR GLUTEAL ARTERY AND RIGHT LATERAL CIRCUMFLEX FEMORAL ARTERY WERE INJURED, RESULTING IN HEMORRHAGIC SHOCK. THE PATIENT THEN DIED OF MULTIPLE ORGAN FAILURE (DATE NOT SPECIFIED). STATEMENT FROM BBAJ LEGAL DEPARTMENT: BASED ON THE INFORMATION PROVIDED, WE CONCLUDE THAT THIS WAS CAUSED BY THE DOCTOR INJURING THE ARTERIES (RIGHT SUPERIOR GLUTEAL ARTERY, RIGHT LATERAL CIRCUMFLEX FEMORAL ARTERY) DURING THE NAIL REMOVAL SURGERY, AND THAT THIS WAS NOT A CASE OF MALFUNCTION OF THE MEDICAL EQUIPMENT. ADDITIONAL DETAILS WERE REQUESTED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887741 COLLECT.NO.QAS O/T INTERLOCKING NAILS INTERLOCKING NAILS NDH AESCULAP AG AE-QAS-O559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death