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	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 it was reported, by a sales representative via sems-06050533, that an ar-9603-3639-3 combination humeral trial was worn down.This was discovered during an unspecified procedure, with no patient harm.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-9603-3639-3 serial/batch number 1027262123 was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection found that the material (radel) shows burrs, cracks, and nicks at the connecting holes at the front and back face.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.Device manufactured date 2021.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18049129
• Report Number: 1220246-2023-08505
• Device Sequence Number: 20843450
• Product Code: HWT
• UDI-Device Identifier: 00888867309029
• UDI-Public: 00888867309029
• 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): 05/09/2024

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
• Device Lot Number: 1027262123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown