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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867310001), received between Apr 26, 2024 and Oct 15, 2025 — classified as 1 injury, 3 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  ON 9/19/2025, 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 RETURNED

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

  MAUDE report 23277873 ↗
• MalfunctionJun 4, 2024Defective Device; Defective Device

  ON 1/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE 3.0MM PROXIMAL DRILL BIT FROM AN AR-4158DS-14B DYNANITE PIP KIT, DID NOT FIT OVER THE K-WIRE. ANOTHER KIT WAS OPENED AND THE NEW 3.0MM DRILL BIT WAS USED WITH THE K-WIRE FROM THE PREVIOUS KIT. THIS WAS DISCOVERED DURING A HAMMERTOE PROCEDURE ON (B)(6) 2023. CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457345 ↗
• MalfunctionMay 6, 2024Component Missing; Component Missing

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4158DS-14B DYNANITE PIP KIT CONTAINED (2) 3.0 CANNULATED DRILL BITS RATHER THAN (1)2.5 AND (1)3.0. THIS WAS DISCOVERED DURING A HAMMER TOE PROCEDURE ON (B)(6) 2024, WHERE THE IMPLANT WAS STILL USED ALONG WITH A DRILL BIT FROM THE AR-4158DS-12B.

  Patient problems: Insufficient Information

  MAUDE report 19247518 ↗
• MalfunctionApr 26, 2024Break; Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4158DS-14B DYNANITE PIP HAMMERTOE IMPLANT HAS BROKEN AFTER NINE WEEKS OF POST OPERATION. THE IMPLANT APPEARS TO BE FUSED AND THE SURGEON IS NOT PLANNING ON REMOVING IT AS OF NOW. THIS WAS DISCOVERED DURING A POST OPERATIVE VISIT ON (B)(6) 2022, VIA X-RAYS. ADDITIONAL INFORMATION HAS BEEN RECEIVED ON 6/14/2022: THE PROCEDURE TOOK PLACE ON (B)(6) 2022 AND IT WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 19190746 ↗