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	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 17-mar-2026, it was reported by a sales representative via (b)(4) that an ar-9530xs-03 humeral insert trial was broken.This was discovered during a procedure with no patient involvement or harm reported.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation was confirmed.One unpackaged ar-9530xs-03 trial, humeral insert, 33 +3 batch number 465327 was received for evaluation.Visual inspection identified a device fracture, with additional material damage including dents and nicks.A functional test was not performed due to device damage.The most likely cause of the reported failure is use error, including excessive force applied to the device, with potential contribution from age-related degradation, manufactured in 2022.

• 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: 24818987
• Report Number: 1220246-2026-02077
• Device Sequence Number: 9693601
• 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): 06/18/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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