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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
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 12/10/2024, it was reported by a sales representative via (b)(4) that an ar-9511-2 univers revers impactor / extractor adapter broke off and no longer works as intended, and the ar-9512 arthrex univers revers¿ stem/cup extraction adapter handle sheared off while threaded into the ar-9511-2 univers revers impactor / extractor adapter.All pieces that broke from both devices were retrieved from the patient.The case was completed successfully using a different ar-9511-2 univers revers impactor / extractor adapter.No adverse event or patient harm was reported.This was discovered during a procedure.Additional information has been requested.
Event or Problem Description
Additional information was received on 12/31/2024: this was discovered during a reverse total shoulder procedure on (b)(6) 2024.There was no case delay and no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged, ar-9512, arthrex univers revers¿, batch 37622224, was received for investigation.Visual inspection noted damage to the threaded tip.A piece of the device was broken.No fragments were received for investigation.Functional testing could not be performed due to the device being damaged.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.The manufacturing date is 2022.

• 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: 21093496
• Report Number: 1220246-2025-09248
• Device Sequence Number: 8732276
• Product Code: MDM
• UDI-Device Identifier: 00888867061866
• UDI-Public: (01)00888867061866(11)221227(10)37622224
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 02/18/2025

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
• Device Lot Number: 37622224
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 02/03/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/23/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• 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