MAUDE Adverse Event Report: ARTHREX, INC. MODULAR VAULTLOCK DRILL GUIDE, SMALL; ORTHOPEDIC MANUAL SURG INSTR

Model Number	MODULAR VAULTLOCK DRILL GUIDE, SMALL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a facility representative reported via (b)(4) that the tip of an ar-9215-1-03 quick connect handle broke off within an ar-9231-vl-01 drill guide during a case, but the patient was not affected.Additional information received on 07/18/25: there was damage to the vaultlock drill guide (please see attached image).There were no loose fragments.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9231-vl-01 batch 052124 was received for evaluation.Visual inspection revealed that the device shows heavy signs of wear, with nicks and damage all around it.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure is user error.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.

• Brand Name: MODULAR VAULTLOCK DRILL GUIDE, SMALL
• 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: 22701853
• Report Number: 1220246-2025-03222
• Device Sequence Number: 13014466
• Product Code: LXH
• UDI-Device Identifier: 00888867398931
• UDI-Public: 00888867398931
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: MODULAR VAULTLOCK DRILL GUIDE, SMALL
• Device Catalogue Number: AR-9231-VL-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 10/06/2025
• 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