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

Model Number	MODULAR VAULTLOCK DRILL GUIDE, LARGE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/28/2025, it was reported by a sales representative via (b)(4) that an ar-9215-1-03 universal quick connect handle and an ar-9231-vl-03 univers vaultlock glenoid drill guide broke in a case.Nothing broke off inside the patient.The case was completed successfully by removing the vaultlock guide and continuing the case without a handle.This was discovered during a eclipse total shoulder procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
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 confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted the tip of an ar-9231-vl-03 universal quick connect handle had broken off inside of an glenoid drill guide with batch: 052124.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 07-feb-2022.
Event or Problem Description
Additional information was received on 02/28/2025: there was no case delay or added anesthesia administered to the patient.No adverse effects were reported.

• Brand Name: MODULAR VAULTLOCK DRILL GUIDE, 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: 21354205
• Report Number: 1220246-2025-00368
• Device Sequence Number: 15690950
• Product Code: LXH
• UDI-Device Identifier: 00888867398955
• UDI-Public: (01)00888867398955(11)220207(10)052124
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/09/2025

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, LARGE
• Device Catalogue Number: AR-9231-VL-03
• Device Lot Number: 052124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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