MAUDE Adverse Event Report: ARTHREX, INC. GLENOID INSERTER/IMPACTOR, MEDIUM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GLENOID INSERTER/IMPACTOR, MEDIUM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024 it was reported by a sales representative via (b)(4) that an ar-9241-02 glenoid inserter/impactor broke during the case.It is now missing the soft blue component.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the poly inserter/impactor was broken off from univers vaultlock® glenoid inserter / impactor, medium.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred during the insertion and/or removal process of the device over repeated usage.

• Brand Name: GLENOID INSERTER/IMPACTOR, MEDIUM
• 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: 21125110
• Report Number: 1220246-2025-09348
• Device Sequence Number: 7497788
• Product Code: LXH
• UDI-Device Identifier: 00888867377127
• UDI-Public: 00888867377127
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/18/2025

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: GLENOID INSERTER/IMPACTOR, MEDIUM
• Device Catalogue Number: AR-9241-02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/18/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown