MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID 2NDARY RMR,SZ S; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNI GLENOID 2NDARY RMR,SZ S
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
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 30-dec-2025, it was reported by a sales representative via (b)(4) that an ar-9126r-01 instrument is dull.Noticed during a case but able to be completed with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.-visual inspection noted that the edges of the reamer head of the arthrex universal glenoid¿ secondary reamer size s, were chipped/damaged, and signs of wear and tear along the device.It was noted rust spot.-functional testing was not performed due to the damage to the device.Per dfu-0023-eo - e.Inspection and maintenance - 2.Devices with cutting functions or sharp points become dull with continuous use.This condition does not indicate a device defect.This condition indicates normal wear.Dull devices may require replacement if they no longer perform as designed.Inspection prior to use should include verifying the cutting ability and sharpness of these points and edges.The most likely cause of the reported failure can be attributed to wear and tear damage resulting from repeated drilling and extended use of the device in the field.

• Brand Name: UNI GLENOID 2NDARY RMR,SZ S
• 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: 24082727
• Report Number: 1220246-2026-00225
• Device Sequence Number: 21278025
• Product Code: LXH
• UDI-Device Identifier: 00888867057586
• UDI-Public: (01)00888867057586(11)230227(10)250224203
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/16/2026

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: UNI GLENOID 2NDARY RMR,SZ S
• Device Catalogue Number: AR-9126R-01
• Device Lot Number: 250224203
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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