DYNANITE PIP - BENT 16 W/INSERTER ONLY

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.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON (B)(6) 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.