Arthrex® AR-4158P-12BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867310056), received between Sep 2, 2025 and Oct 15, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction 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 RETURN

  Patient problems: Arthralgia; Failure of Implant; Malunion of Bone

  MAUDE report 23277720 ↗
• InjurySep 2, 2025Patient Device Interaction Problem; Patient Device Interaction 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 A POST-OPERATIVE INFECTION. THE EVENT OCCURRED ON (B)(6) 2021 FOLLOWING SURGICAL IMPLANTATION OF THE DEVICE. THE INFECTION HAS BEEN DOCUMENTED WITH CAUSALITY CURRENTLY UNDETERMINED. ADDITIONAL INFORMATION WAS RECEIVED ON 8/11/2025. THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2021 USING AN AR-4158P-12B DYNANITE PIP. THE PATIENT WAS TREATED POSTOPERATIVELY WITH KEFLEX ANTIBIOTICS. THE IMPLANTS REMAINED IN THE PATIENT, AND NO REVISION SURGERY WAS PERFORMED. THE PATIENT COMPLETED THE FINAL FOLLOW-UP VISIT ON (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 22939407 ↗