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 Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
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 10/30/2024, it was reported by a sales representative via (b)(4) that an ar-9512 arthrex univers revers stem/cup extraction adapter handle had an issue after removing the trial suture cup from the joint during an rtsa procedure on (b)(6) 2024.The surgeon had difficulty extracting the apex stem broach trial from the humerus.It appeared the trial broach kicked when impacting the trial suturecup.The broach handle was not able to extract the trial stem.The surgeon was then recommended to use the ar-9512 threaded rod to extract the trial stem, but was unsuccessful.The trial stem was removed after about 15 minutes with a bone hook.It was unclear if the ar-9512 was damaged in this particular process of attempted extraction, but inspection after the case showed that the threads appeared flattened/damaged (photo is attached).No pieces broke inside the patient and the case was completed successfully.This was noticed during use, and no harm was reported to the patient.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-9512 serial/batch number (b)(6) was received for evaluation.Functional testing was not performed because the device's thread was damaged and could damage the mating part.The visual evaluation found that the tip's thread has nicks and degradation of the laser marks was also noted.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Device manufacturing date, 2021.

• 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: 20771679
• Report Number: 1220246-2024-08596
• Device Sequence Number: 4387981
• Product Code: MDM
• UDI-Device Identifier: 00888867061866
• UDI-Public: 00888867061866
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/28/2025

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 REVS STEM/CUP EXTRACT ADPTR HNDL
• Device Catalogue Number: AR-9512
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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