MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID REAMER, MEDIUM; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS VAULTLOCK GLENOID REAMER, MEDIUM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed.(1) unpackaged ar-9229grpp was received for evaluation.Visual inspection noted no apparent issues with the device other than wear signs along the inferior edge of the cutting rim.No functional test was performed to determine the device's cutting ability.A cause can be attribute to normal wear and tear from usage in the field.
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems the surgeon was using the ar-9229grpp attempting to ream the glenoid, the reamer was dull.The surgeon removed the reamer from the joint and clean it off, then reapply with more force than should be required.After doing this multiple times we were able to get a prepped surface for our implant.This was discovered during use in a tsa procedure on (b)(6) 2022.No patient affect reported.

• Brand Name: UNIVERS VAULTLOCK GLENOID REAMER, MEDIUM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19215637
• Report Number: 1220246-2024-02643
• Device Sequence Number: 8198416
• Product Code: LXH
• UDI-Device Identifier: 00888867239081
• UDI-Public: 00888867239081
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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 REAMER, MEDIUM
• Device Catalogue Number: AR-9229GRPP
• Device Lot Number: 04511813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2018
• 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