MAUDE Adverse Event Report: ARTHREX, INC. FOOTPRINT FEMORAL ACL GUIDE, LEFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	FOOTPRINT FEMORAL ACL GUIDE, LEFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
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 (b)(6) 2025, a sales representative reported via (b)(4) that an ar-1510fl footprint femoral acl guide left appears bent at the tip, causing a bad trajectory due to the flip cutter firing incorrectly through the guide.The case was completed successfully.No pieces broke off inside the patient.This was discovered during an acl reconstruction procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 concluded that the most likely cause of the reported failure is user error, including the instrument having been damaged prior to use.Directions for use dfu-0023-eo instruments c.Validation repeated processing has minimal effect on these devices.End of life is normally determined by wear and damage due to the intended use.The user assumes liability and is responsible for the use of a damaged and dirty device.E.Inspection and maintenance 1.Arthrex non-sterile devices are precision medical devices and must be used and handled with care.Inspect the devices for damage prior to use and at all stages of handling thereafter.If damage is detected, do not use the device prior to consulting the manufacturer for guidance.The complaint allegation was not confirmed, and no evidence of the failure was received.

• Brand Name: FOOTPRINT FEMORAL ACL GUIDE, LEFT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 21356711
• Report Number: 1220246-2025-00383
• Device Sequence Number: 15412820
• Product Code: MDM
• UDI-Device Identifier: 00888867018297
• UDI-Public: (01)00888867018297(11)220301(10)43212205
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/05/2025

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: FOOTPRINT FEMORAL ACL GUIDE, LEFT
• Device Catalogue Number: AR-1510FL
• Device Lot Number: 43212205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown