MAUDE Adverse Event Report: ARTHREX, INC. TRIAL, LARGE, PEGGED GLENOID; ORTHOPEDIC MANUAL SURG INSTR

Model Number	TRIAL, LARGE, PEGGED GLENOID
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/21/2024, it was reported by a sales representative via (b)(4) that an ar-9236-03 pegged glenoids center peg broke off of the main component.This occurred during a case, the patient was unaffected and they proceeded as normal.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-9236-03, serial/batch number (b)(6), was received for investigation.No functional test was performed due to the damage of the device.Visual evaluation noted that the center peg was broken off.The most likely cause can be attributed misuse due to hitting the device with another object, prying/leveraging the device, or excessive bending forces applied during use.
Event or Problem Description
Additional information was provided on 08/27/2024 where it was stated this event occurred during an anatomic tsa on (b)(6) 2024.The central peg fell off when the trial was taken out of the patient.The patient had a normal bone quality.The procedure continued as per the technique guide.

• Brand Name: TRIAL, LARGE, PEGGED GLENOID
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 20190548
• Report Number: 1220246-2024-07512
• Device Sequence Number: 20531207
• Product Code: HWT
• UDI-Device Identifier: 00888867059498
• UDI-Public: 00888867059498
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/15/2024

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: TRIAL, LARGE, PEGGED GLENOID
• Device Catalogue Number: AR-9236-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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