MAUDE Adverse Event Report: ARTHREX, INC. AVL ANGLED REAMER SLEEVE ASSEMBLY, 15; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/19/2025, a sales representative reported via (b)(4) that an (2) ar-9297-15 univers vaultlock® augmented glenoid angled reamer sleeves heat welded with the ar-9676 angled reamers.This occurred during a total shoulder procedure on (b)(6) 2025.The procedure was completed successfully.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-9297-15, angled reamer sleeve, batch number 052116, was received for investigation.Visual evaluation of the returned device noted nicks and striations in its inner diameter on both the proximal and distal ends.Additionally, the device was returned with an ar-9676 stuck inside.Functional testing was not performed due to the damage of the devices.The most likely cause for the reported failure can be attributed to misuse due to a force perpendicular to the drive shaft being applied while the device is spinning.This applied force creates an excess of friction and heat that ultimately has the potential to cause the device to cease functioning as intended.Application of this force perpendicular to the drive shaft is not needed for the device to function, nor is it recommended that the user do this during normal clinical use.When used usually, this issue is unlikely to present itself, which suggests that the handling of the device greatly impacts whether or not it will seize.For this reason, the direct cause is considered to be device misuse.

• Brand Name: AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
• 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: 21537265
• Report Number: 1220246-2025-00831
• Device Sequence Number: 15221710
• Product Code: LXH
• UDI-Device Identifier: 00888867350038
• UDI-Public: 00888867350038
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
• Device Catalogue Number: AR-9297-15
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown