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	06/06/2025
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 06/06/2025, it was reported by a sales representative via (b)(4) that an ar-9597-10 angled sleeve is fused with the drive shaft.Discovered during a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9597-10 was received for investigation.Visual evaluation noted the mating part was stuck within the internal diameter of the device.Functional testing was not performed due to the internal damage observed.The most likely cause of the reported failure is user error, such as misaligned insertion or prying/leveraging the device during insertion, which causes interference and damage to the device.Complaint allegation is 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: 22385997
• Report Number: 1220246-2025-02710
• Device Sequence Number: 7101249
• Product Code: LXH
• UDI-Device Identifier: 00888867343436
• UDI-Public: (01)00888867343436(11)240112(10)37622319
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/22/2025

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: 37622319
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown