MAUDE Adverse Event Report: ARTHREX, INC. 36+3 / 39 COMBINATION HUMERAL TRIAL; ORTHOPAEDIC TEMPLATE

Model Number	36+3 / 39 COMBINATION HUMERAL TRIAL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/17/2024 it was reported by a sales representative via (b)(4) that an ar-9603-3639-3 univers revers trial was chipped during the trialing process.This occurred during a revers tsa.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was provided on (b)(6) 2024 where the sales representative stated that the patient had a good bone quality.The fragment was retrieved from the patient.A mosquito forcep was used to grab the trial.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 was able to conclude a most likely cause.The most likely cause can be attributed to damage incurred during the insertion and/or removal process of the device.

• Brand Name: 36+3 / 39 COMBINATION HUMERAL TRIAL
• 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: 19718499
• Report Number: 1220246-2024-06685
• Device Sequence Number: 18224685
• Product Code: HWT
• UDI-Device Identifier: 00888867309029
• UDI-Public: 00888867309029
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2025

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: 36+3 / 39 COMBINATION HUMERAL TRIAL
• Device Catalogue Number: AR-9603-3639-3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 05/13/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 12/18/2024; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown