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	04/19/2024
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 4/22/2024, it was reported by a sales representative via (b)(4)that an ar-9236-03pp universe vaultlock glenoid trial (lot: s624tg000) had a central peg break off and was easily removed from the central hole.The case was completed by opening an additional trial (lot: s804tg000), and that central peg started to break but not completely.There was a visible crack around the central peg, and it was loose.There were no adverse effects on the patient or pieces of the trial left in the patient.This was discovered during an eclipse procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 4/25/2024: the ar-9236-03pp universe vaultlock glenoid trial (lot: s624tg000) central peg on the trial broke off during insertion of the trial into the prepared glenoid.When the second trial (ar-9236-03pp universe vaultlock glenoid trial lot: s804tg000) was removed from the prepared glenoid the surgeon noticed the central peg on the trial was loose and there was a crack.This likely occurred during the insertion or removal of the trial from the prepared glenoid.The case was not delayed due to this incident.
Additional Manufacturer Narrative
One unpackaged ar-9236-01pp was received for investigation.Visual inspection identified that the edges around the device were chipped.Functional testing has been conducted, and the central post has been removed from the univers vaultlock¿ glenoid trial, large.The central post was broken off.The most likely cause can be attributed to use error due to the damage incurred during the insertion and/or removal process of the device.Refer to investigation photos.Complaint allegation is confirmed.

• 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: 19345153
• Report Number: 1220246-2024-03473
• Device Sequence Number: 7129965
• Product Code: KWS
• UDI-Device Identifier: 00888867250697
• UDI-Public: 00888867250697
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 08/20/2024

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: S804TG000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown