MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, SMALL; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS VAULTLOCK GLENOID, SMALL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/08/2024, it was reported by a sales representative via (b)(4) that an ar-9106-01 arthrex® univers vaultlock¿ glenoid broke.This occurred during a case on (b)(6) 2024.No additional information was provided, and additional information has been asked.
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.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-9106-01, univers vaultlock¿ glenoid, was received for investigation.Visual evaluation noted that the central peg is broken.Additionally, the damage to the thread was observed on the broken fragment.Functional test could not be performed due to the damage of the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device by applying excessive force and over-stressing the device.

• Brand Name: UNIVERS VAULTLOCK GLENOID, SMALL
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 19468296
• Report Number: 1220246-2024-04930
• Device Sequence Number: 3554919
• Product Code: KWS
• UDI-Device Identifier: 00888867239319
• UDI-Public: 00888867239319
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: UNIVERS VAULTLOCK GLENOID, SMALL
• Device Catalogue Number: AR-9106-01
• Device Lot Number: S81301079
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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