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

Model Number	ANGLED REAMER, DRIVE SHAFT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
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 10/31/2025, a facility representative reported via (b)(4) that an ar-9597-10 10-degree angled reamer sleeve was cold-welded to an ar-9676 angled reamer drive shaft.They confirmed being unsure of the type of procedure performed, but the event wasn¿t noticed in the case, and there were no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9597-10, angled reamer sleeve, batch number 37622051, 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.This is a known manufacturing issue and ncr-27796 has been opened to address it.Refer to investigation photos.Complaint allegation is confirmed.

• 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: 23534762
• Report Number: 1220246-2025-05051
• Device Sequence Number: 15724354
• Product Code: LXH
• UDI-Device Identifier: 00888867324954
• UDI-Public: (01)00888867324954(11)200716(10)022028
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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
• Device Lot Number: 022028
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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