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

Model Number	OUTRIGGER TARGETING GUIDE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
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 03/07/2025, it was reported by a sales representative via (b)(4) that an ar-8973-01 outrigger targeting guide would not allow the attachment screw rod to pass through its respective sheath to engage the nail and hold it to the outrigger.It seems there is a screw halfway down the sheath of the outrigger that blocks the attachment screw rod.The screw appears to be part of the outrigger, but there is no way to remove it as it looks internal.No adverse effects on the patient.This was discovered during a procedure, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-8973-01 outrigger targeting guide batch number: 052210 was received for investigation.Visual evaluation of the returned device noted a screw was visible through the hub attachment tube and was observed to be causing an obstruction.Functional testing was not performed due to the obstruction noted.The most likely cause for the reported failure can be attributed to wear and tear incurred from repeated/extended usage in the field.Manufactured date: 16-sep-2022.

• 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: 21667468
• Report Number: 1220246-2025-01125
• Device Sequence Number: 20877943
• Product Code: LXH
• UDI-Device Identifier: 00888867301832
• UDI-Public: (01)00888867301832(11)220916(10)052210
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/04/2025

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: 052210
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown