BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CANNULATED

    MDR report key: 9861048 · Received March 20, 2020

    Report

    Report Number
    8030965-2020-02148
    Event Type
    Injury
    Date Received
    March 20, 2020
    Report Date
    February 24, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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. 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.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN (B)(6) 2016 TO (B)(6) 2018. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: WANG, X.-D., LAN, H., AND LI, K.-N. (2019), TREATMENT OF FEMORAL NECK FRACTURES WITH CANNULATED SCREW INVASIVE INTERNAL FIXATION ASSISTED BY ORTHOPAEDIC SURGERY ROBOT POSITIONING SYSTEM, ORTHOPAEDIC SURGERY, VOL. 11 (5) PAGES 864-872, DOI: 10.1111/OS.12548 (CHINA). THE AIM OF THIS RETROSPECTIVE CASE-CONTROL STUDY IS (I) TO COMPARE THE CLINICAL EFFICACY OF CANNULATED SCREW INTERNAL FIXATION ASSISTED BY THE ORTHOPAEDIC SURGERY ROBOT POSITIONING SYSTEM AND TRADITIONAL CANNULATED SCREW INTERNAL FIXATION IN THE TREATMENT OF FEMORAL NECK FRACTURES; AND (II) TO INVESTIGATE THE ADVANTAGES OF CANNULATED SCREW INTERNAL FIXATION ASSISTED BY THE ORTHOPAEDIC SURGERY ROBOT POSITIONING SYSTEM IN THE TREATMENT OF FEMORAL NECK FRACTURES. BETWEEN JANUARY 2016 TO JULY 2018, A TOTAL OF 128 PATIENTS WERE INCLUDED IN THE STUDY. 63 PATIENTS (30 MALES AND 33 FEMALES) WITH AN AVERAGE AGE OF 49.03 YEARS (RANGE 25 TO 64 YEARS) WERE TREATED WITH CANNULATED SCREW ASSISTED BY ORTHOPEDIC ROBOT POSITIONING SYSTEM (ORTHOPAEDIC SURGERY ROBOT GROUP), AND 65 PATIENTS (31 MALE AND 34 FEMALE) WITH AN AVERAGE AGE OF 49.80 YEARS (RANGE 29 TO 64 YEARS) WERE TREATED WITH TRADITIONAL CANNULATED SCREW (TRADITIONAL SURGERY GROUP). SURGERY WAS PERFORMED USING (7.3 MM) CANNULATED SCREW (DEPUY SYNTHES COMPANY, SWITZERLAND). ALL PATIENTS WERE FOLLOWED UP FOR 12 TO 24 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: TRADITIONAL SURGERY GROUP: THE SUCCESS RATE OF ONE-TIME NAIL PLACEMENT WAS 49.23% (32/65) IN THE TRADITIONAL SURGERY GROUP. 1 PATIENT HAD OSTEONECROSIS OF THE FEMORAL HEAD. IN 2 PATIENTS, THE CLINICAL CURATIVE EFFECT WAS GRADED ACCORDING TO THE HARRIS HIP SCORE AS POOR. 2 PATIENTS HAD LOOSENING OF INTERNAL FIXATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES CANNULATED SCREWS. THIS REPORT IS FOR ONE UNKNOWN CANNULATED SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322884 UNK - SCREWS: CANNULATED SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention