MAUDE Adverse Event Report: ARTHREX, INC. GLENOSPHERE SIZING GUIDE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GLENOSPHERE SIZING GUIDE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/05/2025, it was reported by a sales representative via (b)(4) that an ar-9664-sg glenosphere sizing guide did not load onto the manual driver handle.When the tech pulled the glenosphere sizing guide off the handle the spring fell out.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confiirmed based on the image of the ar-9664-sg, with batch 6402190210, showed significant surface damage.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to wear and tear damage incurred over time.The manufacturing date was in 2019.

• Brand Name: GLENOSPHERE SIZING GUIDE
• 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: 22350266
• Report Number: 1220246-2025-02693
• Device Sequence Number: 15596753
• Product Code: LXH
• UDI-Device Identifier: 00888867298316
• UDI-Public: (01)00888867298316(11)190528(10)6402190210
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/14/2025

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: GLENOSPHERE SIZING GUIDE
• Device Catalogue Number: AR-9664-SG
• Device Lot Number: 6402190210
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown