MAUDE Adverse Event Report: ARTHREX, INC. REAMER, LOW PROFILE 11.5MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REAMER, LOW PROFILE 11.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2025
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 07/24/2025, it was reported by a distributor via (b)(4) that an ar-1411lp-50 reamer blade broke.This occurred during a acl reconstruction on (b)(6) 2025 when the blade of the low-profile reamer broke during tibial reaming and the piece was not retrieved.The broken piece remained in the patient even after x ray was used to try to retrieve it.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information was provided on (b)(6) 2025, where it was stated, the patient had a good bone quality, young patient between 20-25 years old.There was small delay in care because the surgeon attempted few times to retrieve the metal debris.It is difficult to indicate exactly duration.No additional anesthesia administered.There were no x-rays available to attach.
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 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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.Btb autograft acl reconstruction surgical technique video ref: vid1-001191-en-us.

• Brand Name: REAMER, LOW PROFILE 11.5MM
• 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: 22777413
• Report Number: 1220246-2025-03424
• Device Sequence Number: 9167020
• Product Code: LXH
• UDI-Device Identifier: 00888867016897
• UDI-Public: (01)00888867016897(11)240801(17)290731(10)4197150978
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2025

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: REAMER, LOW PROFILE 11.5MM
• Device Catalogue Number: AR-1411LP-50
• Device Lot Number: 4197150978
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 12/09/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/28/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown