MAUDE Adverse Event Report: ARTHREX, INC. KEEL GLENOID TRIAL, LARGE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	KEEL GLENOID TRIAL, LARGE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/25/2025, it was reported by a sales representative via (b)(4) that an ar-9219 large keel glenoid trial was cut in the center, and spd is deeming it part unusable moving forward.The case carried on and was completed successfully.Instruments will be sent back for evaluation.These are not single use devices.Instruments are consigned inventory.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an unpackaged ar-9219, with batch number 0086, revealed signs of wear on both the anterior and posterior sides: surface damage, cracks and chips.Therefore, arthrex was able to deduce the most likely cause of the complaint as a wear-and-tear issue.The device will inevitably sustain damage over time due to continuous mechanical forces applied to it.

• Brand Name: KEEL GLENOID TRIAL, LARGE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21594645
• Report Number: 1220246-2025-00919
• Device Sequence Number: 8939100
• Product Code: LXH
• UDI-Device Identifier: 00888867059153
• UDI-Public: (01)00888867059153(10)0086
• 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): 08/27/2025

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: KEEL GLENOID TRIAL, LARGE
• Device Catalogue Number: AR-9219
• Device Lot Number: 0086
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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