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

Model Number	AUGMENTED VAULTLOCK DRILL GUIDE, M 25R
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/28/2023, it was reported by a sales representative via sems that an ar-9215-1-03 universal quick connect handle snapped off and got stuck inside an ar-9231-02ag-25r glenoid drill guide.Nothing broke inside the patient, and the case was completed successfully without further issues.This was discovered during an eclipse tsa procedure on (b)(6) 2023.Additional information received on 2/23/2023: case was completed by utilizing a mallet and poly tipped impactor to gently secure glenoid drill guide in glenoid.The 6mm superior drill was drilled and held the guide in place.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.Upon visual evaluation, some abrasion marks were noted on the device.Also, the laser mark faded.Functional testing was performed and noticed the device did not work as required.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: AUGMENTED VAULTLOCK DRILL GUIDE, M 25R
• 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: 19360384
• Report Number: 1220246-2024-03595
• Device Sequence Number: 3727722
• Product Code: LXH
• UDI-Device Identifier: 00888867350267
• UDI-Public: 00888867350267
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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, M 25R
• Device Catalogue Number: AR-9231-02AG-25R
• Device Lot Number: 37622116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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