BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL

    MDR report key: 14820575 · Received June 25, 2022

    Report

    Report Number
    1020279-2022-03112
    Event Type
    Injury
    Date Received
    June 25, 2022
    Date of Event
    June 25, 2009
    Report Date
    August 2, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE (B)(4). LU GANG, CHEN PINGBO, & LU FANGFA. (2009). FEATURES OF INTRAMEDULLARY NAIL INTERTAN FOR INTERTROCHANTERIC FRACTURES: RETROSPECTIVE ANALYSIS OF 19 CASES. CHINESE JOURNAL OF CLINICAL REHABILITATIVE TISSUE ENGINEERING RESEARCH, 13(26), 5162-5166. DOI: 10.3969/J.ISSN.1673-8225.2009.26.037.

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE DATA PRESENTED IN THE AGED ARTICLE DID NOT PROVIDE INSIGHT OR RELEVANCE TO CURRENT CLINICAL OUTCOMES FOR THE PRODUCT/DEVICE. 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 ARE 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. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL PROBABLE CAUSES FOR THIS EVENT COULD INCLUDE BUT NOT LIMITED TO PROCEDURAL/USER ERROR, SURGICAL COMPLICATION, FIT/SIZING ISSUE AND/OR HEALING FACTORS. 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. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "FEATURES OF INTRAMEDULLARY NAIL INTERTAN FOR INTERTROCHANTERIC FRACTURES: RETROSPECTIVE ANALYSIS OF 19 CASES", ONE (1) PATIENT WHO INITIALLY UNDERWENT PRIMARY IMPLANTATION WITH AN INTERTAN NAIL TO TREAT A FALLING-CAUSED INTERTROCHANTERIC FRACTURE EXPERIENCED A FEMORAL NECK SHORTENING GREATER OR EQUAL THAN TEN (10) MM AS DEMONSTRATED DURING IMAGING FOLLOW UP CONDUCTED IN A MEAN POSTOPERATIVE PERIOD OF 6.2 MONTHS. ANY MEASURES TAKEN TO RESOLVE THIS COMPLICATION WERE NOT PROVIDED WITHIN THE REPORT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072551 UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW