MAUDE Adverse Event Report: ARTHREX, INC. CORING REAMER, 10MM WITH COLLARED PIN; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CORING REAMER, 10MM WITH COLLARED PIN
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2024, it was reported by an arthrex subsidiary employee via sems (b)(4) that the surgeon has used the coring reamer, ar-1224s, in many cases and is familiar with the technique.He followed the procedure to drill the tibial tunnel and upon exiting into joint, the tip of the coring reamer expanded and flowered open.There are multiple splits in the reamer near the tip.He was able to remove the drill and no remains were inside the joint.The issue was noticed after the device exited the cavity.There was no adverse effect on the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded the cause of the reported failure.The most likely cause of the reported failure is user error.Excess drilling force, in conjunction with any angulation changes of the drill during reaming, may result in coring reamer deviation or failure of the device.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: CORING REAMER, 10MM WITH COLLARED PIN
• 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: 18816265
• Report Number: 1220246-2024-01234
• Device Sequence Number: 20928515
• Product Code: LXH
• UDI-Device Identifier: 00888867005648
• UDI-Public: 00888867005648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: CORING REAMER, 10MM WITH COLLARED PIN
• Device Catalogue Number: AR-1224S
• Device Lot Number: 15112500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown