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 Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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 01/15/2025, it was reported by a sales representative via email that an ar-9530s-03 arthrex® univers revers¿, trial humeral insert 36 +3 had the plastic cracking.A new implant was used.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 02/12/2025: there were no photos taken of the issue.The same product was used to complete the case.There was no case delay or added anesthesia to the case.This occurred during a rtsa procedure on (b)(6) 2025.
Additional Manufacturer Narrative
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.The most likely cause of this failure is attributed to wear and tear resulting from repeated insertion and/or removal of the device, as well as extended use in the field.

• 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: 21334884
• Report Number: 1220246-2025-00309
• Device Sequence Number: 3849450
• Product Code: LXH
• UDI-Device Identifier: 00888867062146
• UDI-Public: (01)00888867062146(11)230410(10)585279
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 07/16/2025

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
• Device Lot Number: 585279
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: Not provided; 06/24/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/25/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown