BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EXPERT FEMORAL NAIL

    MDR report key: 14411037 · Received May 16, 2022

    Report

    Report Number
    8030965-2022-03229
    Event Type
    Injury
    Date Received
    May 16, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: EXPERT FEMORAL NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CAMACHO CARRASCO, P., ET AL. (2021), A MODIFIED CABLE WIRING TECHNIQUE WITH C SHAPED PASSER THROUGH A MINI OPEN APPROACH TO ASSIST REDUCTION IN FEMORAL FRACTURES, EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, VOL. XX, PAGES 1-7 (SPAIN) IN THE PRESENT REPORT, A MODIFIED CERCLAGE WIRING THROUGH A MINIMALLY INVASIVE TECHNIQUE IS DESCRIBED, USING A CONVENTIONAL CANNULATED C-SHAPED PASSER. BETWEEN JANUARY 2014 AND JUNE 2019, 31 PATIENTS WERE OPERATED USING A MODIFIED ASSISTED CERCLAGE WIRING REDUCTION THROUGH A MINIMALLY INVASIVE APPROACH. ALL PATIENTS HAD FEMORAL FRACTURES (INTER- OR SUBTROCHANTERIC, SUPRACONDYLAR OR PERIPROSTHETIC) IN WHICH CLOSED REDUCTION WAS NOT SATISFACTORY AND THE INSERTION OF A CERCLAGE WIRE WAS REQUIRED TO IMPROVE REDUCTION QUALITY AND TO INCREASE STABILITY AS AN ADJUNCT TO AN INTERNAL FIXATION. THERE WERE 10 MALES AND 21 FEMALES WITH A MEAN AGE OF 81.03 YEARS (RANGE 24¿94 YEARS). IMPLANTS USED WERE: CEPHALOMEDULLARY NAILS WERE 15 PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA, SYNTHES, OBERDORF, SWITZERLAND), 3 TROCHANTERIC FEMORAL NAIL-ADVANCED (TFNA, SYNTHES, OBERDORF, SWITZERLAND), 3 TROCHANTERIC FEMORAL NAIL (TFN, SYNTHES, OBERDORF, SWITZERLAND) RETROGRADE NAILS WERE 5 EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL (SYNTHES, OBERDORF, SWITZERLAND). PLATES USED WERE 3 DISTAL FEMUR LOCKING PLATES LCP CONDYLAR PLATE 4.5/5.0 (SYNTHES, OBERDORF, SWITZERLAND). THE MEAN DURATION OF FOLLOW-UP WAS 19.80 MONTHS (RANGE 12¿60 MONTHS, EXCLUDING THE DECEASED PATIENT). ALL CASES WERE FOLLOWED A MINIMUM OF 12 MONTHS WITH THE PREVIOUS EXCEPTION. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 7 PATIENTS DIED ONE YEAR AFTER SURGERY. A (B)(6) FEMALE PATIENT WHO WAS TREATED WITH A TFN LONG NAIL DIED. AN (B)(6) FEMALE PATIENT WHO WAS TREATED WITH A PFNA LONG NAIL DIED. A (B)(6) FEMALE PATIENT WITH A DISTAL DIAPHYSEAL FRACTURE FIXED WITH A RETROGRADE INTRAMEDULLARY NAIL, REQUIRED A SECONDARY PROCEDURE AT APPROXIMATELY 5 MONTHS POSTOPERATIVELY DUE TO A DELAY OF THE HEALING PROCESS AND BONE HEALING WAS ACHIEVED AFTER NAIL DYNAMIZATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES CONSTRUCTS: EXPERT FEMORAL NAIL. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476066 UNK - CONSTRUCTS: EXPERT FEMORAL NAIL NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention