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	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On 1/15/2025, an fda medwatch notification was received via email.A patient reported having an arthrex shoulder replacement surgery about four years ago.The patient reported worsening symptoms after the surgery on (b)(6) 2020.Less than four years after the initial surgery, the patient underwent revision surgery to a revers total shoulder replacement.The patient reported that during the revision surgery, it was discovered that the glenohumeral component was damaged, and one of the pegs was sheered completely off, causing pain, swelling, and pious amounts of fluid buildup.No further information was provided.Additional information requested on 1/23/2025.Additional information received on 1/23/025: during the initial surgery on (b)(6) 2020, an ar-9106-01 arthrex univers vaultlock glenoid, an ar-9301-02 arthrex eclipse cage screw, and an ar-9301-43cpc arthrex eclipse trunion were implanted.The patient started to experience pain and sought out medical treatment.The patient underwent two debridement procedures, in which the missing peg was discovered.The third procedure was the revers total shoulder replacement which occurred on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
Additional information was received: the initial surgery date was on (b)(6) 2020.
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 a patient-specific event.

• 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: 21337006
• Report Number: 1220246-2025-00313
• Device Sequence Number: 8550432
• Product Code: QHQ
• UDI-Device Identifier: 00888867059931
• UDI-Public: (01)00888867059931(11)190228(17)231231(10)18.01106
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: ECLIPSE CAGE SCREW M, 35MM
• Device Catalogue Number: AR-9301-02
• Device Lot Number: 18.01106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: Not provided; 09/04/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/21/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown