MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANGLED REAMER, DRIVE SHAFT
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/21/2025, it was reported by a sales representative via (b)(4) that an ar-9676 angled reamer drive shaft was stuck inside an ar-9597-10 angled reamer sleeve and cold welded together.This was discovered during a reverse total shoulder procedure and the case was completed with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: the complaint allegation is confirmed.One unpackaged ar-9676, serial/batch number unk, was received for investigation.The ar-9676 was stuck inside ar-9597-10, serial/batch number (b)(6).The visual evaluation revealed heavy scratches and lines at the proximal area because the device was received and stuck inside the ar-9597-10, and a more in-depth visual inspection could not be performed.Functional testing was not conducted because the device was stuck inside ar-9597-10; however, an attempt to move/rotate found the device was firmly stuck inside and not moving in any direction.The observed condition is most likely due to heavy use.Eco-41381 was implemented to reduce the outside diameter of the reamer.Ncr-27796 was opened to address the issue of the parts binding/sticking together.

• Brand Name: ANGLED REAMER, DRIVE SHAFT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 21535616
• Report Number: 1220246-2025-00794
• Device Sequence Number: 8050290
• Product Code: LXH
• UDI-Device Identifier: 00888867324954
• UDI-Public: 00888867324954
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: ANGLED REAMER, DRIVE SHAFT
• Device Catalogue Number: AR-9676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/15/2025
• 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