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

Model Number	ANGLED REAMER SLEEVE, 10°
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/22/2025, it was reported by a sales representative via sems (b)(4) that an ar-9597-10 angled reamer sleeve and an ar-9676 angled reamer drive shaft were welded together and did not spin freely.This was discovered during the case 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.- one unpackaged ar-9597-10, angled reamer sleeve, batch number 37622248, 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.- functional testing was performed with a good-known ar-9676 and the device rotated without resistance as intended.- no problem found.- refer to investigation photos.- complaint allegation is not confirmed.

• 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: 23031630
• Report Number: 1220246-2025-03818
• Device Sequence Number: 9491484
• Product Code: LXH
• UDI-Device Identifier: 00888867343436
• UDI-Public: (01)00888867343436(11)230703(10)37622248
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/07/2025

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: 37622248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown