MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER SLEEVE, 20°; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANGLED REAMER SLEEVE, 20°
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/23/2024, it was reported by an arthrex employee via sems-06693573 that an ar-9676 angled reamer, and an ar-9597-20 angled reamer sleeve cold welded together.This occurred during a case that was completed using new devices.This resulted in a 30-minute delay.
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-9597-20, serial/batch number (b)(6), was received for investigation.The device arrived separated from the ar-9676 batch 022338 for evaluation.The visual evaluation revealed heavy scratches and lines at the collar and at the distal end.Functional testing was conducted with the received mating parts ar-9676, batch 022338.It was noted that when attempting to insert the shaft into the ar-9597-20, resistance was encountered, which prevented a proper fit.Eco-41381 was implemented.The changes being implemented are due to a product improvement initiative to address complaints related to the ar-9676 drive shaft seizing/binding during use ncr-27796 was opened to address the issue of the parts binding/sticking together.

• Brand Name: ANGLED REAMER SLEEVE, 20°
• 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: 20613012
• Report Number: 1220246-2024-08416
• Device Sequence Number: 12966855
• Product Code: LXH
• UDI-Device Identifier: 00888867343450
• UDI-Public: (01)00888867343450(11)230505(10)37622246
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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, 20°
• Device Catalogue Number: AR-9597-20
• Device Lot Number: 37622246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• 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