MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE PIP - BENT 12 W/INSERTER ONLY; SMOOTH FIXATION PIN

Model Number	DYNANITE PIP - BENT 12 W/INSERTER ONLY
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
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 a post-operative infection.The event occurred on (b)(6) 2021 following surgical implantation of the device.The infection has been documented with causality currently undetermined.Additional information was received on 8/11/2025.The initial surgery took place on (b)(6) 2021 using an ar-4158p-12b dynanite pip.The patient was treated postoperatively with keflex antibiotics.The implants remained in the patient, and no revision surgery was performed.The patient completed the final follow-up visit on (b)(6) 2022.
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.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.Since the complaint device was not returned and no evidence of the failure was provided, neither physical inspection nor a review of images could be performed.As a result, the complaint allegation could not be confirmed.

• Brand Name: DYNANITE PIP - BENT 12 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: 22939407
• Report Number: 1220246-2025-03696
• Device Sequence Number: 15932702
• Product Code: HTY
• UDI-Device Identifier: 00888867310056
• UDI-Public: 00888867310056
• 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): 11/14/2025

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 12 W/INSERTER ONLY
• Device Catalogue Number: AR-4158P-12B
• Device Lot Number: 10568155
• 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: 11/12/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown