BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL

    MDR report key: 14342207 · Received May 9, 2022

    Report

    Report Number
    1020279-2022-02267
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    February 20, 2021
    Report Date
    July 29, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL RELEVANT PATIENT INFORMATION BE PROVIDED, THIS CASE WOULD BE RE-ASSESSED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. POSSIBLE CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO TRAUMATIC INJURY, JOINT TIGHTNESS, PATIENT CONDITION OR SURGICAL TECHNIQUE. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.INTERNAL COMPLAINT REFERENCE NUMBER: CASE-2022-00103527-1

    Additional Manufacturer Narrative · 0

    (PRODUCT CODE UPDATED FROM JSD TO JDS.).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "THE V-EFFECT IN FIXATION OF INTERTROCHANTERIC FRACTURES WITH PROXIMAL FEMORAL NAILS", ONE (1) PATIENT HAD V-EFFECT AND A BAD REDUCTION QUALITY AFTER TREATMENT OF A RIGHT INTERTROCHANTERIC FRACTURE WITH TRIGEN INTERTAN. THE PATIENT DID NOT REQUIRE RE-OPERATION, BUT IT WAS NOT REPORTED HOW THE ADVERSE EVENT WAS RESOLVED. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426011 UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC.
    789517 UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other