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 Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/28/2024
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 8/5/2024, an fda medsun notification was received via email.A facility representative reported that an ar-1408lp low profile reamer, 8 mm broke while in the medullary canal of the proximal radius.The patient was taken to the operating room for a right elbow distal biceps repair with augment.The biceps demonstrated some interstitial tearing, thus, the surgeon elected to proceed with a bio brace augment.This was then sutured to the biceps tendon utilizing 0 vicryl sutures.Following this, the arthrex fiberloop was then placed through the tendon and the augment.This was then placed through the pec button and sized.Then, the proximal portion of the hole, was reamed, in which the biceps tendon was docked.Unfortunately, at this point, one of the tongs of the arthrex 8mm reamer drill bit broke while in the medullary canal of the proximal radius.The surgeon could not remove it, and the surgeon proceeded to dunk the biceps tendon and verify the correct position.This was then dunked into the hole and sutured.This demonstrated a very nice repair with good fixation.The tourniquet was then deflated to make sure there were no bleeders.The wound was then copiously irrigated and closed in a layered fashion utilizing 2-0 monocryl and 3-0 monocryl.Sterile dressing was then applied, and the patient was placed into a posterior splint.The procedure was performed in (b)(6) 2024.
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 improper bone preparation and/or prying/leveraging 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: 20138795
• Report Number: 1220246-2024-07360
• Device Sequence Number: 3187003
• Product Code: LXH
• UDI-Device Identifier: 00888867016729
• UDI-Public: 00888867016729
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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
• Device Catalogue Number: AR-1408LP
• Device Lot Number: 15125305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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