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

Model Number	DYNANITE PIP - BENT 14 W/INSERTER ONLY
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	03/01/2023
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 07/11/2025, a facility representative reported that a patient enrolled in the clinical study titled prospective study of hammer toe fixation using an intramedullary nitinol implant, experienced multiple complications following device implantation.The initial event occurred on (b)(6) 2023, when the patient sustained a stress fracture of the operative toe.The stress fracture was documented after the surgical procedure involving the intramedullary nitinol implant.Following this, the subject also experienced two significant falls, resulting in emergency room visits on (b)(6) 2023 and (b)(6) 2024.The causal relationship between the implant and these subsequent incidents is currently undetermined.Additional information was received on 8/11/2025.The initial surgery took place on (b)(6) 2023 using an ar-4158p-14b dynanite pip.The patient reported no memory of a specific incident leading to the issue.At the time, the patient was still in a short boot, so no additional stabilization was necessary.The implants remain in the patient; however, by the 1-year follow-up visit on (b)(6) 2024, one arm of the implant was noted to be broken.No revision surgery was performed.The patient completed the final follow-up visit on (b)(6) 2024.
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 probable contributing factors to the reported failure include a patient-specific event.Directions for use dfu-0286-1 - dynanite® pip implant.C.Contraindications.5.Conditions that tend to limit the patient¿s ability or willingness to restrict activities or follow directions during the healing period.E.Warnings.8.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.11.Detailed instructions on the use and limitations of this device should be given to the patient.The complaint allegation could not be confirmed, as the device was not returned for evaluation, and no supporting evidence of the reported failure was provided.

• Brand Name: DYNANITE PIP - BENT 14 W/INSERTER ONLY
• 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: 22950956
• Report Number: 1220246-2025-03700
• Device Sequence Number: 9591482
• Product Code: HTY
• UDI-Device Identifier: 00888867310070
• UDI-Public: (01)00888867310070(11)200417(17)250331(10)10846278
• 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
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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 Expiration Date: 03/31/2025
• Device Model Number: DYNANITE PIP - BENT 14 W/INSERTER ONLY
• Device Catalogue Number: AR-4158P-14B
• Device Lot Number: 10846278
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown