BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL

    MDR report key: 15237101 · Received August 16, 2022

    Report

    Report Number
    1020279-2022-03672
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    May 1, 2022
    Report Date
    August 22, 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

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THE ALLEGED DEEP INFECTIONS THAT WERE REPORTED IN 2 PATIENTS AFTER HAVING AN INTERNAL FIXATION PROCEDURE USING THE TRIGEN INTERTAN WERE NOT IMPLANT OR PROCEDURE RELATED. THE AUTHOR OF THE STUDY CONFIRMED THAT THE INFECTIONS WERE CAUSED BY AIR FILTRATION MALFUNCTION. IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT PURSUANT TO 21 CFR §803.

    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, TWO (2) PATIENTS SUFFERED FROM A DEEP INFECTION WITH A SINUS TRACT. THE INFECTIONS WERE RESOLVED WITH NAIL REMOVAL AND DEBRIDEMENT WITH ANTIBIOTIC SPACER IMPLEMENTATION. THE OUTCOME OF THE PATIENT IS UNKNOWN. UPON AN UPDATE FROM THE AUTHOR, IT WAS STATED THAT THESE DEEP INFECTIONS WERE NOT IMPLANT-RELATED; INSTEAD, THEY WERE CAUSED BY AIR FILTRATION MALFUNCTION. AT THE BEGINNING OF (B)(6) 2022, IT WAS DISCOVERED THAT THERE WAS A TEMPORARY MALFUNCTION WITH THE AIR FILTRATION SYSTEM OF THE OPERATING ROOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950767 UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL NAIL, FIXATION, BONE, METALLIC NDH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R