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

Model Number	ANGLED REAMER SLEEVE, 20°
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/12/2024, it was reported by a sales representative via (b)(4) that an ar-9676 angled reamer drive shaft was welded together with the ar-9597-20 angled reamer sleeve, 20° and caused the surgeon's wrist to suddenly twist and makes the reaming difficult.A second ar-9597-20 angled reamer sleeve, 20°, was used, and the incident occurred a second time.The case was carried out successfully with a different reamer sleeve and driveshaft.This was discovered during an rtsa procedure on 12/10/2024, with no reported patient harm.Additional information was received on 12/17/2024: there was no case delay reported.
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.Complaint allegation is confirmed.One unpackaged, ar-9597-20 serial/batch number (b)(6), was received for investigation.Functional testing was performed with an ar-9676 angled reamer and found the devices would not twist together and get stuck.Visual inspection noted signs of wear on both the distal and proximal end of the device.The most likely cause for the reported failure can be attributed to misuse due to interference with the mating instrument.

• 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: 21102979
• Report Number: 1220246-2025-09281
• Device Sequence Number: 20991888
• Product Code: LXH
• UDI-Device Identifier: 00888867343450
• UDI-Public: (01)00888867343450(11)231220(10)37622318
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/19/2025

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: 37622318
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• 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