MAUDE Adverse Event Report: ARTHREX, INC. DUALCOMP HINDFOOT NAIL, 10.5 X 180 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	DUALCOMP HINDFOOT NAIL, 10.5 X 180 MM
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received on 04/22/2025: this occurred on (b)(6) 2025 during a ttc fusion procedure.The ar-9090-01s dualcomp hindfoot was removed from the patient after the failure.The peek pin holding the nitinol slider proximal part broke apart in the patient, with no fragments to retrieve.The case was completed with a new nail, the same size as the original.The case was delayed 20 minutes.No adverse effects on or after the surgery for the patient were reported.
Event or Problem Description
On 04/08/2025, it was reported by a sales representative via (b)(4), an ar-9090-01s dualcomp hindfoot failed to tension to the necessary position, rendering it unusable.As a result, the case was delayed for an unspecified period.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
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 ar-9090-11s, dual comp hindfoot nail, batch number 15096995, was returned for evaluation.Upon visual evaluation, it was noted that the peek pin was sheared off, as is expected when inserting the nail.Additionally, the implant was tensioned to the intended position.No problem found.The complaint allegation was not confirmed.

• Brand Name: DUALCOMP HINDFOOT NAIL, 10.5 X 180 MM
• 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: 21935716
• Report Number: 1220246-2025-01799
• Device Sequence Number: 7985154
• Product Code: HSB
• UDI-Device Identifier: 00888867305618
• UDI-Public: (01)00888867305618(11)240213(17)290131(10)15206195
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K221031
• 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,Followup
• Report Date (Section B): 09/11/2025

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: DUALCOMP HINDFOOT NAIL, 10.5 X 180 MM
• Device Catalogue Number: AR-9090-01S
• Device Lot Number: 15206195
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: Not provided; 09/03/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/27/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown