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

Model Number	AR-1409LP-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 2/20/2025, an fda medwatch notification was received via email.A facility representative reported that a patient had an alc procedure on (b)(6) 2025.An x-ray was performed forty-eight hours post-procedure, and a foreign body was identified in the patient's knee.From the x-ray it could not be identified if it was the arthrex 9.5 mm reamer or the flipcutter.The patient underwent a second surgery to have the foreign body retrieved and it was identified that the tip of the drill bit broke off.No further information was provided.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, d1, d4, g3.
Event or Problem Description
Additional information was received on 03/10/2025: the part and lot number of the reamer was ar-1409lp-50 low profile reamer, 9.5 mm from lot 4248152395.The second surgery was on 01/16/2025.There were no arthrex parts explanted or implanted.The patient's status is normal post-op acl.An x-ray will be provided when available.
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 a patient-specific event.

• 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: 21549489
• Report Number: 1220246-2025-00847
• Device Sequence Number: 15497568
• Product Code: LXH
• UDI-Device Identifier: 00888867016774
• UDI-Public: (01)00888867016774(11)240901(17)290831(10)4248152395
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AR-1409LP-50
• Device Catalogue Number: AR-1409LP-50
• Device Lot Number: 4248152395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 08/26/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/28/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female