BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL

    MDR report key: 15236950 · Received August 16, 2022

    Report

    Report Number
    1020279-2022-03671
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    May 1, 2022
    Report Date
    October 31, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE CITE: YAPICI, F., ÜÇPUNAR, H., GÜR, V., ONAÇ, O., ALPAY, Y., KARAKÖSE, R., & ÇAMURCU, Y. (2022). FUNCTIONAL AND RADIOLOGICAL COMPARISON OF THREE CEPHALOMEDULLARY NAILS WITH DIFFERENT DESIGNS USED IN THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMUR FRACTURES OF ELDERLY. YASLILARDA INSTABIL INTERTROKANTERIK FEMUR KIRIKLARININ TEDAVISINDE KULLANILAN DIZAYNLARI FARKLI ÜÇ SEFALOMEDÜLLER ÇIVININ FONKSIYONEL VE RADYOLOJIK AÇIDAN KARSILASTIRILMASI. ULUSAL TRAVMA VE ACIL CERRAHI DERGISI = TURKISH JOURNAL OF TRAUMA & EMERGENCY SURGERY : TJTES, 28(5), 668¿677. HTTPS://DOI.ORG/10.14744/TJTES.2020.80733.

    Additional Manufacturer Narrative · 0

    H3, H6: GIVEN THE NATURE OF THE ALLEGED INCIDENT, THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THIS CASE REPORTS, IN A LITERATURE REVIEW, 1 PATIENT SUFFERED FROM DEEP VEIN THROMBOSIS, AFTER HAVING A PRIMARY INTERNAL FIXATION WITH AN INTERTAN NAILING SYSTEM. THIS PATIENT FIRST USED COUMADIN AND ENOXAPARIN FOR THE FIRST 2 WEEKS, THEN CONTINUED TO USE COUMADIN FOR 6 MONTHS, AND FINALLY RECOVERED UNEVENTFULLY AT THE END OF THE 6TH MONTH. NO FURTHER INFORMATION IS AVAILABLE. WITHOUT CLINICAL DOCUMENTATION AND PATIENT SPECIFIC INFORMATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THE CLINICAL ROOT CAUSE OF THE DEEP VEIN THROMBOSIS IS A PROCEDURAL COMPLICATION NOT A PRODUCT FAILURE. THE PATIENT¿S OUTCOME/IMPACT WAS NEWLY REPORTED AS ¿FINALLY RECOVERED UNEVENTFULLY AT THE END OF THE 6TH MONTH.¿ NO FURTHER INFORMATION IS AVAILABLE. 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. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE POST-OPERATIVE HEALING ISSUE AND/OR PATIENT CONDITION. 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 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.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION IN B5. H11: CORRECTED INFORMATION IN H6 (HEALTH EFFECT - IMPACT CODE).

    Description of Event or Problem · 0

    ON THE ON THE LITERATURE REVIEW "FUNCTIONAL AND RADIOLOGICAL COMPARISON OF THREE CEPHALOMEDULLARY NAILS WITH DIFFERENT DESIGNS USED IN THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMUR FRACTURES OF ELDERLY", IT WAS REPORTED THAT, AFTER UNDERGOING A PRIMARY INTERNAL FIXATION WITH AN INTERTAN NAILING SYSTEM, ONE (1) PATIENT SUFFERED FROM DEEP VEIN THROMBOSIS. IT IS UNKNOWN HOW THIS ISSUE WAS SOLVED. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ON THE ON THE LITERATURE REVIEW "FUNCTIONAL AND RADIOLOGICAL COMPARISON OF THREE CEPHALOMEDULLARY NAILS WITH DIFFERENT DESIGNS USED IN THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMUR FRACTURES OF ELDERLY", IT WAS REPORTED THAT, AFTER UNDERGOING A PRIMARY INTERNAL FIXATION WITH AN INTERTAN NAILING SYSTEM, ONE (1) PATIENT SUFFERED FROM DEEP VEIN THROMBOSIS. THIS PATIENT FIRST USED COUMADIN AND ENOXAPARIN FOR THE FIRST 2 WEEKS, THEN CONTINUED TO USE COUMADIN FOR 6 MONTHS WITH AN INR LEVEL BETWEEN 2.5 AND 3, AND FINALLY RECOVERED UNEVENTFULLY AT THE END OF THE 6TH MONTH. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223200 UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL NAIL, FIXATION, BONE, METALLIC NDH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention