MAUDE Adverse Event Report: ARTHREX, INC. 28MM BASEPLATE, 10° FULL AUGMENT SIZER; MANUAL INSTR, GENERAL SURGICAL

Model Number	28MM BASEPLATE, 10° FULL AUGMENT SIZER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2024 it was reported by a sales representative via (b)(4) that an ar-9592-2810 28 mm baseplate 10° full augment sizer broke.This was discovered during the case with no patient harm.Additional information was provided that this was discovered during an rtsa and all fragments were retrieved.
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 device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause for the reported failure can be attributed to user error, including applying excessive force during use.The complaint allegation was not confirmed, and no evidence of the failure was received.

• Brand Name: 28MM BASEPLATE, 10° FULL AUGMENT SIZER
• 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: 21211014
• Report Number: 1220246-2025-00041
• Device Sequence Number: 8071766
• Product Code: LXH
• UDI-Device Identifier: 00888867343726
• UDI-Public: 00888867343726
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 09/05/2025

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: 28MM BASEPLATE, 10° FULL AUGMENT SIZER
• Device Catalogue Number: AR-9592-2810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 09/05/2025
• 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