MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER SLEEVE, 10°; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANGLED REAMER SLEEVE, 10°
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: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-9597-10, serial/batch number (b)(6), was received for investigation.The ar-9676 was stuck inside it.The visual evaluation revealed heavy scratches and lines at the proximal and distal ends.The observed condition is most likely due to heavy use.Functional testing was not conducted because the device ar-9676 was stuck inside.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 SLEEVE, 10°
• 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: 21535617
• Report Number: 1220246-2025-00793
• Device Sequence Number: 15466353
• Product Code: LXH
• UDI-Device Identifier: 00888867343436
• UDI-Public: (01)00888867343436(11)210708(10)37622109
• 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 SLEEVE, 10°
• Device Catalogue Number: AR-9597-10
• Device Lot Number: 37622109
• 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
• Date Device Manufactured: 07/08/2021
• 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