MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II REAMER, 6MM - HUDSON CONNECT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS II REAMER, 6MM - HUDSON CONNECT
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
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 02/19/2025, it was reported by a sales representative via (b)(4) that an ar-9202-02h univers ii reamer was worn.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-9202-02h, batch 04512116 was received for investigation.Visual inspection identified wear and damage to the geometry of the cutting edges of the reamer.The observed condition is consistent with the age of the device.The most likely cause for the reported failure can be attributed to wear and tear.The manufacturing date is 2021.

• Brand Name: UNIVERS II REAMER, 6MM - HUDSON CONNECT
• 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: 21558324
• Report Number: 1220246-2025-00855
• Device Sequence Number: 9601481
• Product Code: LXH
• UDI-Device Identifier: 00888867058262
• UDI-Public: (01)00888867058262(11)210422(10)04512116
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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 II REAMER, 6MM - HUDSON CONNECT
• Device Catalogue Number: AR-9202-02H
• Device Lot Number: 04512116
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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