MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number	ECLIPSE CAGE SCREW M, 35MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-9301-02 arthrex eclipse cage screw (medium) failed to achieve adequate fixation following implantation.All fixation was lost during the initiation of the speedscap repair for the subscapularis, and the implant became loose.Subsequently, a larger-sized cage screw was implanted, which provided stable fixation despite the initial sizing as medium.The procedure was completed successfully without any reported patient harm.This issue was identified during an eclipse tsa procedure performed on (b)(6) 2025.Additional information has been requested on 10/09/2025.
Event or Problem Description
Additional information was received on (b)(6) 2025: the issue was solely related to inadequate fixation; the implant did not fracture or break during the procedure.No detached fragments were present.The case was completed using an ar-9301-03 arthrex eclipse cage screw large.The surgery was delayed by approximately 30¿45 minutes.No additional anesthesia was administered to the patient to the reporter¿s knowledge.No adverse patient effects were reported during or following the procedure due to this issue.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.Per directions for use (dfu) dfu-0181-eo eclipse¿ shoulder prosthesis, revision 6, section g.Precautions.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.2.Surgeons must apply their professional judgment when determining the appropriately sized device based on the specific indication, preferred surgical technique, and patient history.

• Brand Name: ECLIPSE CAGE SCREW M, 35MM
• Common Device Name: TOT ANAT SHOULDR PROSTH, UNCEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23311244
• Report Number: 1220246-2025-04643
• Device Sequence Number: 5788768
• Product Code: QHQ
• UDI-Device Identifier: 00888867059931
• UDI-Public: (01)00888867059931(11)250101(17)291231(10)24.03988
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ECLIPSE CAGE SCREW M, 35MM
• Device Catalogue Number: AR-9301-02
• Device Lot Number: 24.03988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: Not provided; 02/02/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/20/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown