MAUDE Adverse Event Report: ARTHREX, INC. AUGMENTED VAULTLOCK DRILL GUIDE, S 25L; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AUGMENTED VAULTLOCK DRILL GUIDE, S 25L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/08/2025, it was reported by a sales representative via (b)(4) that an ar-9215-1-03 quick connect handle and ar-9231-01ag-25l drill guide broke as the surgeon was drilling the superior and inferior vault lock holes into the glenoid and upon removal the knurled handled snapped off inside of the vault lock drill guide.Both pieces were retrieved.This occurred during use in a case with no patient effect.There was no delay to the case as the surgeon had just finished drilling all the holes.
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.One unpackaged ar-9231-01ag-25l univers vaultlock® augmented glenoid drill guide batch number: 37622043 was received for investigation.Visual evaluation of the returned device noted wear and tear to the device with superficial scratches and discoloration observed.No broken remnants of the mating instrument were observed within the returned device.Functional testing was not performed due to the damage to the returned concomitant device.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.Refer to investigation photos.Complaint allegation is confirmed based on the damage observed to the returned concomitant device.

• Brand Name: AUGMENTED VAULTLOCK DRILL GUIDE, S 25L
• 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: 22091165
• Report Number: 1220246-2025-02225
• Device Sequence Number: 18148149
• Product Code: LXH
• UDI-Device Identifier: 00888867350236
• UDI-Public: 00888867350236
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/08/2025

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: AUGMENTED VAULTLOCK DRILL GUIDE, S 25L
• Device Catalogue Number: AR-9231-01AG-25L
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown