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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
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-(b)(4) that an ar-8973-01 outrigger targeting guide broke during a case while screwing the nail into the jig, it spiraled (see photos).The case was completed successfully with the nail staying on during the case.No pieces broke off inside the patient.This was discovered during an ankle fracture procedure on (b)(6) 2024, with no reported patient harm.Additional information has been requested.
Event or Problem Description
Additional information was received on 12/23/2024: there was no case delay reported.
Additional Manufacturer Narrative
Additional information: b5, g3.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation of the customer-provided pictures noted an ar-8973-01 outrigger targeting guide broke.Refer to attachments.The complaint allegation is confirmed based on the customer-provided pictures.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: 21143577
• Report Number: 1220246-2025-09413
• Device Sequence Number: 9645724
• Product Code: LXH
• UDI-Device Identifier: 00888867301832
• UDI-Public: (01)00888867301832(11)180928(10)711839
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 07/22/2025

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: OUTRIGGER TARGETING GUIDE
• Device Catalogue Number: AR-8973-01
• Device Lot Number: 711839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2018
• 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
• Patient Sex: Unknown