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	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via sems-06878076 that an ar-9530s-03 trial split in half when compressed with a hemostat.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9530s-03 batch number: 250140801 was received for investigation.Visual evaluation of the returned device noted it was broken in half into two pieces.Further visual evaluation noted superficial wear and tear with scratches and indentations observed.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 2015.Complaint allegation is confirmed.

• 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: 22095963
• Report Number: 1220246-2025-02249
• Device Sequence Number: 8022787
• Product Code: LXH
• UDI-Device Identifier: 00888867062146
• UDI-Public: 00888867062146
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/08/2025

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: 250140801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 05/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown