MAUDE Adverse Event Report: ARTHREX, INC. OUTRIGGER TARGETING GUIDE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	OUTRIGGER TARGETING GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/06/2025, a facility representative reported via (b)(4) that an ar-8973-01 outrigger targeting guide broke while trying to screw on the fibulock nail, where the pegs were stripped off.They tried to screw the nail on, but the screw holes no longer matched up with the jig.There were no fragments produced.The procedure was modified to plating as a result of the break.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-8973-01, batch 711835, that displays that the targeting guide is broken.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.

• Brand Name: OUTRIGGER TARGETING GUIDE
• 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: 23300245
• Report Number: 1220246-2025-04609
• Device Sequence Number: 17359486
• Product Code: LXH
• UDI-Device Identifier: 00888867301832
• UDI-Public: (01)00888867301832(11)180910(10)711835
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: OUTRIGGER TARGETING GUIDE
• Device Catalogue Number: AR-8973-01
• Device Lot Number: 711835
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown