MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL CUP REAMER -L/42; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVERS HUMERAL CUP REAMER -L/42
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 01/22/2025, it was reported by a sales representative via (b)(6) that an ar-9508-42 humeral cup reamer has a bent grate and is catching on the reaming pin.This occurred during use in a case with no patient effect.Additional information requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9508-42, humeral cup reamer, batch number: ar09801901, was received for investigation.Visual evaluation of the returned device noted surface damage along the proximal end of the device.There are nicks along the circumference of the openings.The most likely cause for the reported failure can be attributed to wear and tear incurred from repeated usage/reprocessing.Manufactured date: 14-jul-2023.

• Brand Name: UNIVERS REVERS HUMERAL CUP REAMER -L/42
• 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: 21364407
• Report Number: 1220246-2025-00400
• Device Sequence Number: 18283722
• Product Code: LXH
• UDI-Device Identifier: 00888867061569
• UDI-Public: (01)00888867061569(11)230321(10)AR09801901
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 04/01/2025

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 REVERS HUMERAL CUP REAMER -L/42
• Device Catalogue Number: AR-9508-42
• Device Lot Number: AR09801901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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