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	Insufficient Information (4580)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 12/28/2023, it was reported by a sales representative via email that an ar-9236-03pp univers vaultlock glenoid trial, large and an ar-9215-1-03 universal quick connect handle shaft broke for an ar-9231-vl-03 univers vaultlock glenoid drill guide broke.This was discovered during a tsa procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted that an ar-9231-vl-03 glenoid drill guide batch number: 052120 was damaged with deep nicks and scratches observed on the surface of the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18547768
• Report Number: 1220246-2024-00413
• Device Sequence Number: 8985339
• Product Code: LXH
• UDI-Device Identifier: 00888867398955
• UDI-Public: 00888867398955
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 03/18/2025

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: 052120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2021
• 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