DYNANITE PIP - BENT 14MM - W/INSTR

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' EXPERIENCED A CLAW TOE AND UNDERWENT A REVISION OF THE FIFTH TOE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

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

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED ON 10/3/2025. THE PATIENT EXPERIENCED RETAINED STITCHES AND A SMALL ABSCESS ON THE FOURTH TOE. THE PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2023, DURING WHICH AN AR-4158DS-14B DYNANITE PIP WAS PLACED. ON (B)(6) 2023, A RETAINED SUTURE WAS IDENTIFIED PROTRUDING FROM THE DISTAL SKIN NEAR THE NAIL OF THE FOURTH TOE. THIS RETAINED STITCH LED TO THE DEVELOPMENT OF AN ABSCESS IN THE SAME AREA, CAUSING PAIN. THE SUTURE WAS REMOVED DURING THE VISIT, AND THE SITE WAS TREATED WITH A STERILE DRESSING AND TRIPLE ANTIBIOTIC OINTMENT. ON (B)(6) 2023, THE HEALTHCARE PROVIDER NOTED A LUCENCY IN THE FIFTH PROXIMAL INTERPHALANGEAL JOINT, THOUGH THE TOE MAINTAINED GOOD ALIGNMENT. AT THE (B)(6) 2024 VISIT, THE PATIENT REPORTED CONTINUED PAIN IN THE FIFTH TOE, AND RECURRENCE OF A MILD HAMMERTOE DEFORMITY WAS DOCUMENTED. IMPLANT REMOVAL AND K-WIRE FIXATION WERE RECOMMENDED. AS OF THE (B)(6) 2024 VISIT, THE IMPLANT REMAINED INTACT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH THE ORIGINAL AR-4158DS-14B DYNANITE PIP WAS REMOVED, AND A K-WIRE WAS PLACED TO ADDRESS THE CLAW TOE RECURRENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 10/6/2025: THE HEALTHCARE PROVIDED INDICATED THAT THE IMPLANT HAD TO BE REMOVED AFTER THE (B)(6) 2024 VISIT DUE TO CUT-OUT FROM THE PROXIMAL PHALANX AND PROGRESSIVE PLANTARFLEXION RELATIVE TO THE AXIS OF THE PROXIMAL PHALANX.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D1, D2A, D2B, D4, D6A, D6B, G3, G4, 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 IS A PATIENT-SPECIFIC EVENT DUE TO FACTORS SUCH AS INSUFFICIENT BONE QUALITY, ANATOMICAL VARIABILITY, OR SUBOPTIMAL FIXATION CONDITIONS AT THE TIME OF IMPLANTATION. PER DFU-0286-1: C. CONTRAINDICATIONS 1. INSUFFICIENT QUANTITY OR QUALITY OF BONE. 2. BLOOD SUPPLY LIMITATIONS AND PREVIOUS INFECTIONS, WHICH MAY RETARD HEALING. 3. FOREIGN BODY SENSITIVITY. WHERE MATERIAL SENSITIVITY IS SUSPECTED, APPROPRIATE TESTS SHOULD BE MADE AND SENSITIVITY RULED OUT PRIOR TO IMPLANTATION. 4. ANY ACTIVE INFECTION OR BLOOD SUPPLY LIMITATIONS. 5. CONDITIONS THAT TEND TO LIMIT THE PATIENT¿S ABILITY OR WILLINGNESS TO RESTRICT ACTIVITIES OR FOLLOW DIRECTIONS DURING THE HEALING PERIOD. 6. THE USE OF THIS DEVICE MAY NOT BE SUITABLE FOR PATIENTS WITH INSUFFICIENT OR IMMATURE BONE. THE PHYSICIAN SHOULD CAREFULLY ASSESS BONE QUALITY BEFORE PERFORMING ORTHOPEDIC SURGERY ON PATIENTS WHO ARE SKELETALLY IMMATURE.