BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: 3.5 MM CANNULATED

    MDR report key: 14831073 · Received June 27, 2022

    Report

    Report Number
    8030965-2022-04369
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ASIF, M. ET AL. (2018), A CONSECUTIVE CASE SERIES OF 166 FIRST METATARSOPHALANGEAL JOINT FUSIONS USING A COMBINATION OF CUP AND CONE REAMERS AND CROSSED CANNULATED SCREWS, THE JOURNAL OF FOOT & ANKLE SURGERY, VOL. 57, PAGES 462¿465 (UNITED KINGDOM). THE PRESENT STUDY REPORTS ON A SINGLE-SURGEON, CONSECUTIVE SERIES OF 166 CONSECUTIVE CASES IN 147 PATIENTS WHO HAD UNDERGONE FIRST MTPJ FUSION. FROM FEBRUARY 2009 TO DECEMBER 2015, 166 CONSECUTIVE PROCEDURES IN 147 PATIENTS UNDERWENT FIRST MTJP USING CUP AND CONE REAMERS AND FIXATION USING 2 CROSSED 3.5-MM CANNULATED SCREWS. TWO PARTIALLY THREADED, 3.5-MM CROSSED CANNULATED SCREWS WERE USED FOR DEFINITIVE FIXATION (ORTHO SOLUTIONS LTD., MALDON, UK; DEPUY SYNTHES. THE MEAN AGE IN OUR SERIES WAS 62.18 ± 10.04 (RANGE 31 TO 86) YEARS. THE MEAN DURATION OF FOLLOW UP WAS 60 ± 29.5 (MINIMUM 26, MAXIMUM 183) DAYS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 11 CASES HAD RADIOLOGIC NONUNIONS. FOUR OF THE RADIOLOGIC NONUNIONS WERE CLINICALLY SYMPTOMATIC ANDWERE REVISED WITH A PLATE AND BONE GRAFT AND SUBSEQUENTLY ACHIEVED UNION. METAL WORK REMOVAL WAS REQUIRED IN 11 CASES. IN 3 CASES, THE SCREWS HAD BROKEN. HOWEVER, ALL 3 CASES ACHIEVED UNION. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SYNTHES PARTIALLY THREADED, 3.5-MM CROSSED CANNULATED SCREWS. (3 BROKEN SCREWS) A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019060 UNK - SCREWS: 3.5 MM CANNULATED SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown