DYNANITE PIP - BENT 16 W/INSERTER ONLY

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 CLAW TOE RE-OCCURRENCE AND BROKEN IMPLANT. 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 UNDERWENT INITIAL SURGERY ON (B)(6) 2024, DURING WHICH AN AR-4158P-16B DYNANITE PIP WAS PLACED. AT THE 12-WEEK FOLLOW-UP VISIT ON (B)(6) 2024, THE PATIENT REPORTED RECURRENCE OF CLAW TOE IN THE SECOND TOE, WHICH HAD BEGUN TO CURL AGAIN. IMAGING REVEALED THAT THE IMPLANT HAD BROKEN. THE PATIENT HAD BEEN WEARING A SILICONE SLEEVE ON THE AFFECTED TOE. A FLEXOR TENOTOMY OR REVISION SURGERY TO REMOVE THE IMPLANT AND RE-PIN THE TOE WAS OFFERED, BUT THE PATIENT DECLINED BOTH OPTIONS AT THAT TIME. THE IMPLANT WAS CONFIRMED INTACT DURING THE PREVIOUS VISIT ON (B)(6) 2024, INDICATING THAT THE BREAK OCCURRED SOMETIME BETWEEN THAT DATE AND (B)(6) 2024. NO SPECIFIC INCIDENT WAS REPORTED THAT COULD HAVE CAUSED THE BREAK. ON (B)(6) 2024, THE PATIENT RETURNED TO THE CLINIC EXPRESSING INTEREST IN THE TENOTOMY PROCEDURE. THE PROCEDURE WAS PERFORMED. AT THE 1-YEAR FOLLOW-UP VISIT ON (B)(6) 2025, THE PATIENT WAS REPORTED TO BE FULLY HEALED, WITH THE TOE APPEARING STRAIGHT. THE PATIENT COMPLETED THE STUDY ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/6/2025.: ALTHOUGH THE IMPLANT FRACTURED AT THE JUNCTION WHERE THE TINES MEET THE SCREW-IN PORTION, THE RESULTING DEFORMITY IS NOT LOCATED AT THE PROXIMAL INTERPHALANGEAL ARTHRODESIS SITE. INSTEAD, THE MAJORITY OF THE DEFORMITY WAS PRESENT AT THE DISTAL INTERPHALANGEAL JOINT, CONSISTENT WITH A MALLET TOE. THIS OUTCOME IS ATTRIBUTED TO THE PATIENT¿S SEVERE NEUROPATHY AND THE FACT THAT THE IMPLANT DID NOT SPAN THE DIP JOINT. ADDITINAL INFORMATION WAS RECEIVED ON 10/9/2025: THE REVISION SURGERY TOOK PLACE ON (B)(6) 2024.

Additional Manufacturer Narrative

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 OF THE EVENT IS PATIENT-SPECIFIC, ATTRIBUTED TO UNDERLYING NEUROPATHY.