DYNANITE PIP - BENT 14 W/INSERTER ONLY

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 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.