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

Model Number	UNIVERS VAULTLOCK GLENOID REAMER X-LARGE
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
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 may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-9231grpp, batch 021631 was received for investigation.Visual inspection identified the presence of chipping/general wear across the cutting edges at the distal end of the reamer.A probable cause can be attributed to wear and tear damage accumulated through repeated usage.
Event or Problem Description
On 10/20/2021, it was reported by a sales representative via phone that the following reamers were found to be dull: ar-9288grpp, ar-9229grpp, ar-9230grpp and ar-9231grpp.The surgeon used all reamers, from smallest (ar-9288grpp) to largest (ar-9231grpp) until the depth desired for each was reached.After completion with the extra-large reamer, the surgeon went back to the small reamer and began to ream the insertion site.During reaming the surgeon used force on the small reamer causing the device to ream more than the desired depth on the glenoid.This portion of the procedure was completed using extra cement to achieve good fixation.

• Brand Name: UNIVERS VAULTLOCK GLENOID REAMER X-LARGE
• 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: 19212015
• Report Number: 1220246-2024-02595
• Device Sequence Number: 20589454
• Product Code: LXH
• UDI-Device Identifier: 00888867239104
• UDI-Public: 00888867239104
• 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: Administrator/Supervisor
• 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 X-LARGE
• Device Catalogue Number: AR-9231GRPP
• Device Lot Number: 021631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2016
• 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