MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL
Medical Device Problem Codes	Component Incompatible (1108); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/03/2025, it was reported by a sales representative via (b)(4) that an ar-9512 univers revers¿ stem/cup extraction adapter handle would not thread into the suture cup trial.It was attempted to thread into other suture cups and none worked.This was discovered during an rtsa procedure with no patient harm.The case was completed successfully using another device from a different humeral 2 tray.When compared to the functional inserter, it was found that the complaint device had a smaller diameter at the tip and threads.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
One unpackaged ar-9512 revers¿ stem/cup extraction adapter (batch 37622421) was received for investigation.Visual inspection noted: surface wear and discoloration along the body.Chipping on the handle.Damaged/stripped threads.Functional testing was not performed due to damage to the threads.The most likely cause of the reported failure is wear-and-tear damage sustained in the field over time.The device was manufactured in 2024.The complaint allegation is confirmed.Refer to the attached investigation photos.

• Brand Name: UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL
• 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: 23618778
• Report Number: 1220246-2025-05136
• Device Sequence Number: 15721498
• Product Code: MDM
• UDI-Device Identifier: 00888867061866
• UDI-Public: (01)00888867061866(11)241031(10)37622421
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/11/2026

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 REVS STEM/CUP EXTRACT ADPTR HNDL
• Device Catalogue Number: AR-9512
• Device Lot Number: 37622421
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown