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

Model Number	MODULAR VAULTLOCK DRILL GUIDE, X-LARGE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2023
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 11/27/2023, it was reported by a sales representative via (b)(4) that an ar-9215-1-03 quick connect handle broke off in the ar-9231-vl-04 glenoid drill guide.This occurred during a case.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Complaint is not confirmed.Visual inspection identified the holes of the univers vaultlock® & glenoid drill guide, quick connect, extra large had no presence of pieces of the tip of the ar-9215-1-03.The device shows chips on the surfaces and edges.Functional testing was not performed due to the damage to the device.No problem found.
Event or Problem Description
Additional information was provided on 12/18/2023 where the sales representative stated that this event occurred during an eclipse tsa procedure on (b)(6) 2023.All fragments were retrieved.The drill guide had drills going through it but at the time it broke no power was being used.

• Brand Name: MODULAR VAULTLOCK DRILL GUIDE, X-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: 18385133
• Report Number: 1220246-2023-09596
• Device Sequence Number: 19838636
• Product Code: LXH
• UDI-Device Identifier: 00888867398962
• UDI-Public: 00888867398962
• 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,Followup
• Report Date (Section B): 12/16/2024

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: MODULAR VAULTLOCK DRILL GUIDE, X-LARGE
• Device Catalogue Number: AR-9231-VL-04
• Device Lot Number: 052120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 07/16/2024; 12/18/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 08/05/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown