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

Model Number	GLENOID INSERTER/IMPACTOR, LARGE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
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 07/11/2025, it was reported by a sales representative via (b)(4) that an ar-9241-03 glenoid inserter/impactor broke.The instrument was used correctly but the blue impactor piece broke off the siler inserter.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual evaluation noted that the blue component of the device was broken off.Laser lines were faded/oxidized.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to wear and tear due to repeated use of the device in the field.Manufactured date 2021.

• Brand Name: GLENOID INSERTER/IMPACTOR, LARGE
• 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: 22686911
• Report Number: 1220246-2025-03191
• Device Sequence Number: 18503573
• Product Code: LXH
• UDI-Device Identifier: 00888867377134
• UDI-Public: (01)00888867377134(11)211231(10)37622125
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/17/2025

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, LARGE
• Device Catalogue Number: AR-9241-03
• Device Lot Number: 37622125
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown