BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: CANNULATED

    MDR report key: 18503385 · Received January 12, 2024

    Report

    Report Number
    8030965-2024-00791
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    January 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G5 ¿ 510K: THIS REPORT IS FOR AN UNK - SCREWS: CANNULATED AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D10: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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 CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YU , T., LIU, J., YING, J., & ZHUANG, Y. ( 2023), ¿IN-OUT-IN¿ PERCUTANEOUS REDUCTION TECHNIQUE FOR TREATMENT OF VALGUS-IMPACTED FEMORAL NECK FRACTURES: A TECHNICAL TRICK AND CASE SERIES, ORTHOPAEDIC SURGERY VOL. 15 ( 1 ) PAGES 214¿222 ( CHINA ). THIS RETROSPECTIVE STUDY WAS TO INTRODUCE A NOVEL TECHNICAL TRICK AIMING AT ANATOMICAL REDUCTION OF VALGUS-IMPACTED FEMORAL NECK FRACTURE WITH MINIMALLY INVASIVE PROCEDURE AND SUMMARIZE THE CLINICAL PROGNOSIS IN CASE SERIES.BETWEEN MAY 2017 AND JULY 2020, 24 PATIENTS (7 MEN AND 17 WOMEN) MEAN AGE OF 10.95 ± 54.36 YEARS WITH VALGUS-IMPACTED FEMORAL NECK FRACTURES WERE MANAGED BY ¿IN-OUT-IN¿ PERCUTANEOUS REDUCTION TECHNIQUE (PERCUTANEOUS REDUCTION GROUP). ANOTHER 24 CASES (10 MEN AND 14 WOMEN) MEAN AGE OF 11.23 ± 52.14 YEARS SUFFERING THE FRACTURES UNDERWENT IN SITU FIXATION WERE ENROLLED AS CONTROL GROUP FOR FUNCTION COMPARISON (IN SITU FIXATION GROUP). ALL PATIENTS WERE TREATED BY PERCUTANEOUS PARALLEL CANNULATED SCREW FIXATION IN A TRI-ANGULAR CONFIGURATION. THREE CANNULATED SCREWS (AO/SYNTHES, USA) WITH SUPERO-ANTERIOR, SUPERO-POSTERIOR, AND INFERO-MIDDLE POSITIONS OF FEMORAL NECK WERE ADVANCED FURTHER ACROSS THE FRACTURE LINE WITHIN 5 MM FROM THE SUBCHONDRAL BONE. IN THE IN-SITU GROUP, THREE 7.3-MM PARTIALLY THREADED CANNULATED SCREWS (AO/SYNTHES, USA) WERE USED. ALL PATIENTS WERE FOLLOWED UP FOR 24¿ 42 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PERCUTANEOUS REDUCTION GROUP -1 PATIENT HAD AVN AT 2 YEARS POSTOPERATIVELY. -1 PATIENT SUFFERED FIXATION FAILURE WITH SCREWS RETREAT BUT ACHIEVED BONE UNION FINALLY. IN - SITU GROUP -2 PATIENTS SUFFERED AVN AT LAST FOLLOW-UP. THIS REPORT IS FOR AN UNKNOWN SYNTHES CANNULATED SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4) A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004531 UNK - SCREWS: CANNULATED SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown