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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/7/2024, it was reported by a sales representative via (b)(4) that an ar-9236-03pp univers vaultlock glenoid trial peg broke off during an rtsa procedure on (b)(6) 2024.There was no impact to the patient and the case was completed using a backup set.This was discovered during use, with no reported patient harm.Additional information was received on 6/11/2024: this occurred prior to the case with nothing breaking in the patient.There was no delay in the case.
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-9236-03pp, serial/batch number (b)(6), was received for investigation.No functional test was performed due to the damage of the device.Visual evaluation noted that the center peg was broken off.The most likely cause can be attributed misuse due to hitting the device with another object, prying/leveraging the device, or excessive bending forces applied during use.

• 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: 19671491
• Report Number: 1220246-2024-06582
• Device Sequence Number: 15182917
• Product Code: KWS
• UDI-Device Identifier: 00888867250697
• UDI-Public: 00888867250697
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/25/2024

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 TRIAL, LARGE
• Device Catalogue Number: AR-9236-03PP
• Device Lot Number: S569GT000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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