Arthrex® AR-4158P-14BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867310070), received between Sep 3, 2025 and Sep 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Break; Fracture; Break; Fracture

  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 C

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 22950956 ↗