BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 16120909 · Received January 9, 2023

    Report

    Report Number
    8030965-2023-00294
    Event Type
    Injury
    Date Received
    January 9, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS REPORT IS FOR AN UNKNOWN SCREWS: TRAUMA /UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER FACILITY NAME: (B)(6). 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 GERMANY AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: STRECK, L.E. ET AL. (2022), CLAVICLE STRESS FRACTURE FOLLOWING REVERSE SHOULDER ARTHROPLASTY, ORTHOPADE, VOL. 51, PAGES 246-250 (GERMANY). THIS STUDY PRESENTS A CASE REPORT OF A 69-YEAR-OLD FEMALE PATIENT WHO PRESENTED WITH PROGRESSIVE PAIN AND LIMITED RANGE OF MOTION OF THE LEFT SHOULDER WITHOUT RESPONSE TO CONSERVATIVE THERAPY. WITH A PRE-EXISTING DEFECT ARTHROPATHY, CONVENTIONAL RADIOGRAPHY REVEALED SHOULDER DISLOCATION. DUE TO THE PRONOUNCED PAIN AND THE SEVERE RESTRICTION OF DAILY ACTIVITIES, IMPLANTATION OF AN RSA WAS INDICATED. A TORNIER AEQUALIS REVERSED II PROSTHESIS (NON-SYNTHES PRODUCT) WITH A CEMENTED STEM WAS IMPLANTED WITHOUT COMPLICATIONS. GIVEN THE ANTERIOR DEFECT OF THE GLENOID (WALCH TYPE D), RECONSTRUCTION WAS PERFORMED BY FIXATION OF THE HALF HUMERUS HEAD WITH MAGNESIUM SCREWS (NON-SYNTHES PRODUCTS), FOLLOWED BY IMPLANTATION OF A BASE PLATE WITH LONG POST. AT FIRST, THE POSTOPERATIVE COURSE WAS NORMAL AND THE PATIENT WAS PAIN-FREE. 18 WEEKS AFTER SURGERY, THE PATIENT EXPERIENCED INCREASING PAIN IN THE AREA OF THE CLAVICLE AFTER PHYSIOTHERAPEUTIC ABDUCTION EXERCISES. THE TENTATIVE DIAGNOSIS OF A LATERAL CLAVICLE FRACTURE WITH CRANIAL DISLOCATION OF THE MEDIAL FRAGMENT WAS CONFIRMED RADIOGRAPHICALLY. TREATMENT WITH OPEN REDUCTION AND FIXED-ANGLE PLATE OSTEOSYNTHESIS (5-HOLE LCP WITH EXT; SYNTHES INC., WEST CHESTER, PA, USA) WAS PERFORMED. X-RAYS SHOWED THAT THE MEDIAL FRAGMENT WAS AGAIN DISLOCATED CRANIALLY, 4 LATERAL SCREWS WERE BROKEN OFF, AND ONE LATERAL SCREW WAS DISLOCATED FROM THE FRAGMENT. THE PATIENT REMAINED UNWILLING TO UNDERGO SURGICAL REVISION. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT INVOLVES ONE UNK - SCREWS: TRAUMA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425011 UNK - SCREWS: TRAUMA SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention