MAUDE Adverse Event Report: ARTHREX, INC. REVERS BROACH/TRIAL, SIZE 10; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REVERS BROACH/TRIAL, SIZE 10
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2024
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 12/18/2024, it was reported by a sales representative via sems-06738424 that an ar-9510-10m univers revers¿ broach / trial was damaged from wear and tear.This was discovered during use on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the edges of the geometry feature of the univers revers¿ broach / trial, size 10 had chipped and the bottom surface of the device.Functional testing was not performed due to the damage of the edge's of the geometry feature.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage in the field.

• Brand Name: REVERS BROACH/TRIAL, SIZE 10
• 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: 21149395
• Report Number: 1220246-2025-09442
• Device Sequence Number: 9135036
• Product Code: LXH
• UDI-Device Identifier: 00888867354364
• UDI-Public: (01)00888867354364(11)220203(10)107827
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,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: REVERS BROACH/TRIAL, SIZE 10
• Device Catalogue Number: AR-9510-10M
• Device Lot Number: 107827
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown