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

Model Number	REAMER, LOW PROFILE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/05/2024, an arthrex subsidiary employee reported via (b)(4) that an ar-1408lp low profile reamer, 8 mm, broke during femoral drilling.A small broken fragment remained in the bone, which the surgeon thought best not to remove.The hole was already drilled, and no further action was required, and the case was completed successfully.This was discovered during an acl procedure on (b)(6) 2024, with no patient harm reported.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 01/03/2025: the patient had no adverse effects due to the issue.No revision surgery is needed to remove the fragment.There was no delay in the procedure, and no additional anesthesia was needed.No medical interventions were required for the patient, and there was no reported reduction in the patient's quality of life.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: REAMER, LOW PROFILE
• 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: 21048453
• Report Number: 1220246-2024-09151
• Device Sequence Number: 14305046
• Product Code: LXH
• UDI-Device Identifier: 00888867016729
• UDI-Public: (01)00888867016729(11)190211(17)240131(10)10277488
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/04/2025

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 Expiration Date: 01/31/2024
• Device Model Number: REAMER, LOW PROFILE
• Device Catalogue Number: AR-1408LP
• Device Lot Number: 10277488
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 07/30/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/28/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2019
• 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