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	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/24/2025, it was reported by a sales representative via (b)(4) that an ar-9530xs-03 humeral trial snapped in half during a case.Noticed during a case, device swapped, and case completed with no patient effect.
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.The complaint allegation was confirmed.One unpackaged ar-9530xs-03 trial, humeral insert, 33 +3 batch number 465326 was received for evaluation.Visual inspection found that the device was broken into two pieces; the material around the threaded holes shows nicks, dents, and material loss.A functional test was not performed because the device was damaged.The most likely cause of the reported failure is user error, including the application of excessive force, blunt force, or impact.Directions for use dfu-0023-eor5_fmt_en, instruments: i.Cautions: 2.To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.

• 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: 23777091
• Report Number: 1220246-2025-05581
• Device Sequence Number: 10170763
• Product Code: HWT
• UDI-Device Identifier: 00888867406582
• UDI-Public: (01)00888867406582(11)220609(10)465326
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/09/2026

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: 465326
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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