MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, LARGE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS VAULTLOCK GLENOID TRIAL, LARGE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2024
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 05/29/2024 it was reported by a sales representative via (b)(4) that an ar-9236-03pp univers vaultlock¿ glenoid trials central peg snapped off.This occurred during a tsa procedure on (b)(6) 2024 the case was carried on successfully and the broken peg was retrieved from the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged cannulated drill bit lot number: 032321 that is part of an ar-9928bck-mis mini-open fibertak® achilles speedbridge¿ repair implant system lot number: 15222869 was received for investigation.Visual evaluation noted that the tip of the device was broken and a fragment was missing.Dimensional testing was performed using a caliper id: 1003729.The length of the device was measured and found to be 3.330, indicating that the missing fragment is around.050, as the length dimension specified in drawing c20663 rev 8 is 3.380.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion and/or prying/leveraging the device during use.
Event or Problem Description
Additional information was provided on 6/3/2024 where the sales representative stated that the device failed during removal.After inserting in to the glenoid and trialing, it broke when the surgeon was trying to take it out.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, 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: 19595947
• Report Number: 1220246-2024-06382
• Device Sequence Number: 8410478
• Product Code: KWS
• UDI-Device Identifier: 00888867250697
• UDI-Public: 00888867250697
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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: UNIVERS VAULTLOCK GLENOID TRIAL, LARGE
• Device Catalogue Number: AR-9236-03PP
• Device Lot Number: 1027261621
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 06/03/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 09/25/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• 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