BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - GUIDE/COMPRESSION/K-WIRES

    MDR report key: 14702264 · Received June 15, 2022

    Report

    Report Number
    8030965-2022-04014
    Event Type
    Injury
    Date Received
    June 15, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNK - GUIDE/COMPRESSION/K-WIRES LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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: AITA MA, ET AL. (2021), INTRAMEDULLARY FIXATION WITH HEADLESS SCREWS VERSUS BOUQUET IN UNSTABLE METACARPAL NECK FRACTURES IN ACTIVE PATIENTS: A RANDOMIZED STUDY, REV BRAS ORTOP, VOL. 56, NO. 6, PAGE 717-725, (BRAZIL). THE OBJECTIVE OF THIS STUDY IS TO COMPARE THE RETURN-TO-WORK TIME, WITH THE VISUAL ANALOGUE SCALE SCORE (VAS), THE RATE OF COMPLICATIONS, THE QUICKDASH SCORE, AND THE RADIOLOGY OUTCOMES OF TWO DEFINITIVE INTERNAL FIXATION METHODS IN BOXER FRACTURES IN ACTIVE PATIENTS, OPERATED ON IN THE FIRST WEEK. BETWEEN 2016 AND 2017, 40 PATIENTS WITH UNSTABLE METACARPAL NECK FRACTURES (BOXER FRACTURES) WERE INCLUDED IN THE STUDY. THERE WERE 4 WOMEN AND 36 MEN WITH A MEAN AGE OF 30.46 YEARS (RANGE, 16¿54 YEARS). THE PATIENTS WERE RANDOMIZED AND TREATED TO DEFINITIVE INTRAMEDULLARY FIXATION USING 2 HEADLESS SCREWS OR BOUQUET WIRES. IN THE BOUQUET WIRES GROUP (GROUP A), THERE WERE 20 PATIENTS, AND THEY WERE TREATED USING (2 OR 3) UNKNOWN SYNTHES KIRSCHNER WIRES. IN THE HEADLESS SCREWS GROUP (GROUP B), THERE WERE 20 PATIENTS, AND THEY WERE TREATED USING (2) UNKNOWN SYNTHES CANNULATED COMPRESSION SCREWS. ALL PATIENTS WERE EVALUATED RADIOGRAPHICALLY AND CLINICALLY AT 1, 2, AND 8 WEEKS, AND AT 6 MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: (GROUP A, K-WIRES). A (B)(6) PATIENT HAD PAIN AT THE INSERTION SITE OF K-WIRES WHICH WERE REMOVED AFTER 3 MONTHS. A (B)(6) PATIENT HAD A DECREASED RANGE OF MOTION. (GROUP B, HEADLESS SCREWS). A (B)(6) PATIENT HAD LOSS OF REDUCTION AND DID NOT HAVE FURTHER SURGERY. A (B)(6) PATIENT HAD A DECREASED RANGE OF MOTION. THIS REPORT IS FOR THE UNKNOWN SYNTHES CANNULATED COMPRESSION SCREWS AND UNKNOWN SYNTHES KIRSCHNER WIRES. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203517 UNK - GUIDE/COMPRESSION/K-WIRES GUIDE FZX SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention