MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS APEX IMPACTOR/EXTRACTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVERS APEX IMPACTOR/EXTRACTOR
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.Complaint allegation is confirmed.One unpackaged, ar-9511-2, univers revers¿ impactor / extractor adapter, batch 052224, was received for investigation.Visual evaluation found that the device's 135° threaded hole has a fragment stuck inside.Functional testing could not be performed due to the damage of the device.The most likely cause can be attributed misuse due prying/leveraging the device during use.

• Brand Name: UNIVERS REVERS APEX IMPACTOR/EXTRACTOR
• 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: 21093497
• Report Number: 1220246-2025-09249
• Device Sequence Number: 8732277
• Product Code: LXH
• UDI-Device Identifier: 00888867301870
• UDI-Public: (01)00888867301870(11)221219(10)052224
• 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): 05/29/2025

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 APEX IMPACTOR/EXTRACTOR
• Device Catalogue Number: AR-9511-2
• Device Lot Number: 052224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 05/12/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/23/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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