MAUDE Adverse Event Report: ARTHREX, INC.; TOT ANAT SHOULDR PROSTH, UNCEM

Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
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, it was reported by a sales representative via email that an ar-9349-18 arthrex eclipse humeral head was not engaging properly with the trunnion.The reporter confirmed that the cage screw was fully seated within the trunnion.The team attempted to remove and re-implant the component; however, the eclipse head still would not seat correctly.A new eclipse head was opened and implanted without issue, allowing the procedure to proceed as planned.This was discovered during a total shoulder replacement procedure on (b)(6) 2025.Additional information was received on 16-dec-2025: the issue was identified during use inside the patient.No fragments broke as a result of the issue.The procedure was completed using a different eclipse humeral head, ar-9349-20, 49/20, with the original trunnion.There was no surgical delay or additional anesthesia required.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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.Per surgical technique - eclipse¿ total shoulder arthroplasty system - pag 10 - note: do not overtighten the screw, as this could lead to ineffective fixation.The most likely cause of the reported failure can be attributed to user error with the device due to improper surgical technique during the tightening/overtighten the eclipse with the screw.The device was not returned for evaluation, and no objective evidence (e.G., device analysis, photographs, or supporting documentation) was available to confirm a device-related failure.

• Brand Name: UNK
• 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: 23935632
• Report Number: 1220246-2025-05938
• Device Sequence Number: 12164977
• Product Code: QHQ
• UDI-Device Identifier: 00888867060067
• UDI-Public: (01)00888867060067(11)241001(17)290930(10)244145
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/16/2026

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown