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

Model Number	ANGLED REAMER, ORIENTATION HANDLE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/04/2025, it was reported by a sales representative via (b)(6) that an ar-9678 angled reamer, orientation handle and an ar-9597-10 angled reamer sleeve, 10° were not working properly, and they had to ream the glenoid by hand.No adverse effects on the patient were reported.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
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-9678 was received for investigation.-visual evaluation noted damage on the handle had rust spots.-functional testing was performed and the device got stuck with the matting part.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage in the field.Manufacturing date 2021.-complaint allegation is confirmed.

• Brand Name: ANGLED REAMER, ORIENTATION HANDLE
• 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: 21890662
• Report Number: 1220246-2025-01666
• Device Sequence Number: 8097620
• Product Code: LXH
• UDI-Device Identifier: 00888867324947
• UDI-Public: (01)00888867324947(11)211108(10)052126
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/01/2025

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, ORIENTATION HANDLE
• Device Catalogue Number: AR-9678
• Device Lot Number: 052126
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown