MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS TRIAL 36 +3; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVERS TRIAL 36 +3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
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 08/04/2025, a sales representative reported via (b)(4) that an ar-9530s-03 univers reverse trial broke during a case.The instrument was used correctly, but the small holes inside the trial malfunctioned due to normal wear and tear.The case was completed without any adverse impact, and no extra time was added to the case.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the photos provided which shows wear and tear damage marks to the ar-9530s-03 arthrex univers revers, trial humeral insert 36 +3.Please reference photos attached.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 wear and tear.Dfu-0023-eo: repeated processing has minimal effect on these devices.End of life is normally determined by wear and damage due to repeated use and/or reprocessing.The user assumes liability and is responsible for the use of a damaged or dirty device.

• Brand Name: UNIVERS REVERS TRIAL 36 +3
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 22849442
• Report Number: 1220246-2025-03544
• Device Sequence Number: 15567835
• Product Code: LXH
• UDI-Device Identifier: 00888867062146
• UDI-Public: 00888867062146
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: UNIVERS REVERS TRIAL 36 +3
• Device Catalogue Number: AR-9530S-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown