MAUDE Adverse Event Report: ARTHREX, INC. ANTEGRADE TARGETING MODULE; INTRAMED FIXATN ROD AND ACCESS

Model Number	ANTEGRADE TARGETING MODULE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/21/2025, it was reported by a sales representative via (b)(4) that an 1271-300 targeting module did not line up and was missing the screw hole in the nail by at least 6mm.We were able to complete the case with a freehand lock.Delayed us by about 10 minutes after which the case was completed without issue.No adverse patient issues.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged 1271-300 antegrade targeting module batch number: 213098, was received for investigation.Visual evaluation noted damage to the threads of the device.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.Complaint allegation is confirmed.However, whether this was an out-of-box failure cannot be confirmed due to the damage to the device.

• Brand Name: ANTEGRADE TARGETING MODULE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 22029708
• Report Number: 1220246-2025-02063
• Device Sequence Number: 12799843
• Product Code: LXH
• UDI-Device Identifier: 00848665034073
• UDI-Public: 00848665034073
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: ANTEGRADE TARGETING MODULE
• Device Catalogue Number: 1271-300
• Device Lot Number: 213098
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown