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	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/25/2025, it was reported by a sales representative via (b)(6) that the tip of the ar-9215-1-03 quick connect handle broke off in the attachment slot on the small ar-9231-vl-01 glenoid drill guide.This happened after the surgeon drilled the superior hole and inferior keel and removed the guide.The guide was easily removed from the glenoid.No pieces broke off inside the patient, and the case was completed successfully.This was discovered during a total shoulder arthroplasty procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-9231-vl-01 quick connect, small univers vaultlock glenoid drill guide batch number: 052124 was received for investigation.Visual evaluation of the returned device noted wear and tear to the device with superficial scratches, discoloration, and faded laser markings observed.It was noted that the returned mating device associated with (b)(4) was broken and the fragment no longer remained in the returned ar-9231-vl-01 quick connect, small univers vaultlock glenoid drill guide.Functional testing was performed with a known good ar-9215-1-03 quick connect handle and no issues were noted while mating the two devices.No problem was noted with the functionality of the returned 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 to the mating device during use.

• 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: 21865323
• Report Number: 1220246-2025-01555
• Device Sequence Number: 4721245
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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?: Yes
• Distributor Facility Aware Date: 03/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/31/2025
• 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