MAUDE Adverse Event Report: ARTHREX, INC. TRIAL, LARGE, PEGGED GLENOID; TEMPLATE FOR CLINICAL USE

Model Number	TRIAL, LARGE, PEGGED GLENOID
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that both an ar-9236-03pp glenoid trial and an ar-9236-03 pegged glenoid trial broke immediately upon pushing into the glenoid with hand.This occurred during a total eclipse total shoulder procedure.All was retrieved from the patient.The procedure was completed successfully without a trial being used.
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.Upon visual inspection, it was noted that the central post was broken.The broken piece was note returned for evaluation.The cause remains undetermined, however a probable cause can be attributed to damage incurred during the insertion and/or removal process.

• Brand Name: TRIAL, LARGE, PEGGED GLENOID
• Common Device Name: TEMPLATE FOR CLINICAL USE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15137873
• Report Number: 1220246-2022-05328
• Device Sequence Number: 14856549
• Product Code: HWT
• UDI-Device Identifier: 00888867059498
• UDI-Public: 00888867059498
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/14/2022

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, LARGE, PEGGED GLENOID
• Device Catalogue Number: AR-9236-03
• Device Lot Number: 113601526
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown