MAUDE Adverse Event Report: ARTHREX, INC. UNI REVERS HUMERAL RESECTION DOWNROD; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNI REVERS HUMERAL RESECTION DOWNROD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/18/2024, it was reported by a sales representative via (b)(4) that an ar-9507rgdp-2 univers revers¿ humeral resection downrod broke.This occurred during a case on (b)(6) 2024.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9507rgdp-2 univers revers¿ humeral resection downrod batch number: 052108 was received for investigation.Visual evaluation of the returned device noted that the spring was missing from the groove of the device.Further visual evaluation noted slight discoloration to the surface of the device.Functional testing was not performed due to the missing component.The most likely cause for the reported failure can be attributed to wear and tear incurred from repeated usage/reprocessing.Manufactured date: 27-apr-2021.Refer to investigation photos.

• Brand Name: UNI REVERS HUMERAL RESECTION DOWNROD
• 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: 21143105
• Report Number: 1220246-2025-09400
• Device Sequence Number: 15785414
• Product Code: LXH
• UDI-Device Identifier: 00888867266018
• UDI-Public: 00888867266018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/25/2025

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: UNI REVERS HUMERAL RESECTION DOWNROD
• Device Catalogue Number: AR-9507RGDP-2
• Device Lot Number: 052108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/25/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown