MAUDE Adverse Event Report: ARTHREX, INC. DUALCOMP HINDFOOT NAIL, 12.5 X 210 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	DUALCOMP HINDFOOT NAIL, 12.5 X 210 MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed by the attached x-rays, which shows that that the nitinol did not stretch and the slider did not travel the proper distance during deployment resulting in incomplete exposure of the drill holes required for screw placement.This prevented full deployment of the implant.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 was able to conclude a most likely cause.Dfu-0250-eo - g.Precautions- 5.The use of the cable tensioning device is necessary for joint reduction and to set the nitinol element in the nail implant.Failure to do so will result in misalignment of the interlocking screw hole position in the nail and the mating targeting guide.J.Cleaning and disinfection.All devices are to be cleaned, disinfected, and sterilized prior to each application; this is required.As well for the first use after delivery of the non-sterile devices.Effective cleaning is an indispensable requirement for an effective sterilization of the devices.The most likely cause of the reported failure of the nail not deploying can be attributed to user-related handling¿specifically, set screws in the tensioning device not being adequately cleaned prior to the procedure, preventing proper engagement and allowing cable movement during tensioning.
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, it was reported by an arthrex employee via email that for an ar-9090-10s, dualcomp hindfoot nail, 12.5 x 210 mm, the surgeon was implanting a dual compression hindfoot nail while following the technical guide precisely, the hind foot nail was loaded onto the insertion jig as per technique.The tension cable was loaded precisely as per technical guide.The tension screws were at the most proximal end on the tension guide.All slack was removed from the tension cable as it was inserted into the tension guide.The tension guide screws were tightened with 3 clicks of the torque limiter.The hind foot nail was inserted into the patient.The most distal calcaneal screw was inserted successfully.The most distal tibial screw was inserted successfully.The surgeon used the t handle to tension the nitinol core of the nail.This was tightened until it hit a hard stop.The surgeon then drilled for the proximal calcaneal screw.The drill would not pass through the nail because the nitinol core had not stretched down to expose the nitinol core drill hole.On further lateral inspection the talus nail hole which should be of an oval or elongated shape if the nitinol core had correctly deployed but it did not appear.The nitinol core did not appear to have stretched sufficiently to expose the required drill holes for the procedure to proceed.Under advice, the surgeon detensioned the t handle, loosened the cable in the tensioning device.He wound the part containing the tensioning screws to their most proximal position, retensioned the cable removing all slack, tightened the tensioning device screws and attempted to retension the nitinol core.The core did not stretch to the required position again.The patient had already received a tibal talus fusion from a previous procedure.This was detected during a daul compression hind foot nail procedure on (b)(6) 2025.The procedure was completed successfully as the surgeon decided to use two 7mm compression ft screws to compress the calcaneal talus space.The surgeon was satisfied with the end result but frustrated that the nitinol core had not stretched.The complaint initiator further clarified that the implant did not deploy, he meant that the nitinol core of the nail did not deploy as designed.The nail was implanted.

• Brand Name: DUALCOMP HINDFOOT NAIL, 12.5 X 210 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: 23829165
• Report Number: 1220246-2025-05662
• Device Sequence Number: 9277953
• Product Code: HSB
• UDI-Device Identifier: 00888867305588
• UDI-Public: (01)00888867305588(11)250212(17)300131(10)15388277
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K221031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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, 12.5 X 210 MM
• Device Catalogue Number: AR-9090-10S
• Device Lot Number: 15388277
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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