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

Model Number	GLENOID INSERTER/IMPACTOR, MEDIUM
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
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) 2026, it was reported by a sales representative via sems-07193575 that an ar-9241-02 univers vaultlock medium glenoid inserter/impactor fell apart when the surgeon hit it.This was discovered during use with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation has been confirmed.One unpackaged ar-9241-02 univers vaultlock® glenoid inserter / impacter, medium, batch 37622124, was received for evaluation.During visual inspection, the blue material was found broken, detached from the main part.It was noted that the instrument's laser marks are faded.A functional test was not performed because the device was damaged.The most likely cause of the reported failure is user error, specifically excessive force impacting the device.Directions for use (dfu) dfu-0023-eo revision 5, instruments i.Cautions 2.To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.

• 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: 24290962
• Report Number: 1220246-2026-00467
• Device Sequence Number: 9435812
• Product Code: LXH
• UDI-Device Identifier: 00888867377127
• UDI-Public: 00888867377127
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/16/2026

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
• Device Lot Number: 2797
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown