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); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 07/01/2025, it was reported by a sales representative via (b)(4) that (qty.(b)(4) of an ar-9530s-03 univers revers trial were broken, sharp in the holes where you place the instrument to squeeze them.This was discovered during the case with no patient harm.
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 descriptions, and any additional field information, arthrex was able to determine the most likely cause.The most likely cause for the reported failure is wear and tear damage incurred over time.The manufacturing date was 2017.

• 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: 22569467
• Report Number: 1220246-2025-03016
• Device Sequence Number: 18446554
• Product Code: LXH
• UDI-Device Identifier: 00888867062146
• UDI-Public: (01)00888867062146(11)170518(10)250164601
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/07/2025

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: 250164601
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown