MAUDE Adverse Event Report: ARTHREX, INC. FORWARD CUTTING MONOBLOC REAMER, Ø8.0MM

Model Number	FORWARD CUTTING MONOBLOC REAMER, Ø8.0MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
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 08/26/2025, a facility representative reported via (b)(4) that a 0251-080 8.0mm forward-cutting monobloc reamer broke inside the patient.The patient is okay, and they were able to remove everything and use another reamer to complete the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, noted that the cutting tip was broken off from the shaft.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to wear and tear due to repeatedly cutting, prying/leveraging with the device, and extended use in the field.Manufacturing date 2021.

• Brand Name: FORWARD CUTTING MONOBLOC REAMER, Ø8.0MM
• Common Device Name: REAMER
• 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: 23063827
• Report Number: 1220246-2025-03883
• Device Sequence Number: 9822530
• Product Code: HSB
• UDI-Device Identifier: 00848665001181
• UDI-Public: (01)00848665001181(11)210728(10)211188
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K070444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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: FORWARD CUTTING MONOBLOC REAMER, Ø8.0MM
• Device Catalogue Number: 0251-080
• Device Lot Number: 211188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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