MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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 06/18/2025, a sales representative reported via (b)(4) that an ar-9202 arthrex eclipse¿ and univers¿ orientation pin for resection guides shaft fuses inside the reamer handle.The t handle will not accept the smaller reamers.The patient and physician were not harmed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 for the reported failure can be attributed to misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
• 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: 22508994
• Report Number: 1220246-2025-02876
• Device Sequence Number: 8736237
• Product Code: LXH
• UDI-Device Identifier: 00888867058224
• UDI-Public: 00888867058224
• 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): 10/01/2025

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/ECLIPSE ORIEN PIN FOR RESECT GD
• Device Catalogue Number: AR-9202
• Device Lot Number: 8002407
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/01/2025
• 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