MAUDE Adverse Event Report: ARTHREX, INC. TRIAL HUMERAL INSERT XS/33 +3MM; ORTHOPAEDIC TEMPLATE

Model Number	TRIAL HUMERAL INSERT XS/33 +3MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via (b)(4) that (2) ar-9530xs-03 trial, humeral insert are broken around the holes.This occurred during a case with no effect on the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that scratches and damage were around the edges and holes around the device.The most likely cause of this failure is wear and tear damage incurred over repeated insertion and/or removal processes and extended use in the field of the device.Manufactured date 2022.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: TRIAL HUMERAL INSERT XS/33 +3MM
• Common Device Name: ORTHOPAEDIC TEMPLATE
• 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: 21945302
• Report Number: 1220246-2025-01844
• Device Sequence Number: 8534897
• Product Code: HWT
• UDI-Device Identifier: 00888867406582
• UDI-Public: (01)00888867406582(11)220610(10)465327
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/18/2025

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: TRIAL HUMERAL INSERT XS/33 +3MM
• Device Catalogue Number: AR-9530XS-03
• Device Lot Number: 465327
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown