MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE PIP - BENT 14MM - W/INSTR; SMOOTH FIXATION PIN

Model Number	DYNANITE PIP - BENT 14MM - W/INSTR
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Arthralgia (2355); Malunion of Bone (4529)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 9/19/2025, a facility representative reported that a patient enrolled in the clinical study 'prospective study of hammer toe fixation using an intramedullary nitinol implant' developed mallet toes in all operative toes; however, the implants are intact.Additional information was received on 10/3/2025.The patient underwent initial surgery on (b)(6) 2023, during which an ar-4158ds-16b dynanite pip, an ar-4158p-16b dynanite pip, an ar-4158ds-14b dynanite pip, and an ar-4158p-12b dynanite pip were placed.On (b)(6) 2023, the healthcare provider expressed concern about a possible recurrence of deformity and recommended extension exercises.At the (b)(6) 2023 visit, the patient was noted to have passively correctable claw toes.By (b)(6) 2024, mallet toe deformities were observed in toes 2, 3, 4, and 5, along with pain in the plantar plate area of those toes.An mri was recommended to assess for possible plantar plate tears, but the patient declined.Throughout these visits, the patient experienced mild pain and stiffness in the toes.No treatment was pursued for the mallet toes, and the healthcare provider advised the patient to return if pain worsened.The patient has not returned to the clinic since that recommendation.All implants remain intact and in place.The patient completed the study at the 1-year follow-up visit on (b)(6) 2024.Additional information was received on 10/6/2025: the patient developed mallet toe deformities affecting toes 2, 3, 4, and 5.These deformities were attributed to the fact that the implant did not span the distal interphalangeal joint, despite six weeks of k-wire fixation.
Additional Manufacturer Narrative
Corrected information: d6a.Additional information: g3, h3, h6.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.The most likely cause of the event is patient-specific, attributed to the lack of distal interphalangeal (dip) joint support post-surgery.Additionally, the patient's decision to decline mri imaging limited the ability to further assess potential soft tissue injuries, which may have contributed to the deformity progression.

• Brand Name: DYNANITE PIP - BENT 14MM - W/INSTR
• Common Device Name: SMOOTH FIXATION PIN
• 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: 23277873
• Report Number: 1220246-2025-04560
• Device Sequence Number: 21023340
• Product Code: HTY
• UDI-Device Identifier: 00888867310001
• UDI-Public: (01)00888867310001(11)221108(17)271031(10)15021056
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K190287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DYNANITE PIP - BENT 14MM - W/INSTR
• Device Catalogue Number: AR-4158DS-14B
• Device Lot Number: 15021056
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown