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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867310018), received between Jun 23, 2020 and Dec 4, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionDec 4, 2023Break; Break

  IT WAS REPORTED DURING A SURGERY ON (B)(6) 2020 AR-4158DS-14S WAS IMPLANTED. THE PRODUCT WAS IMPLANTED PER STANDARD SURGICAL TECHNIQUE/PROCEDURE. THE PRODUCT WAS NOTED STILL INTACT DURING A FOLLOW-UP VISIT ON (B)(6) 2020. THE IMPLANTED PRODUCT WAS DISCOVERED BROKEN DURING A FOLLOW-UP VISIT ON (B)(6) 2021. THE SURGEON PLANS TO SCHEDULE A REVISION SURGERY TO REMOVE THE BROKEN IMPLANT. SEE SOURCE DATA ATTACHED.

  Patient problems: Failure of Implant

  MAUDE report 18255252 ↗
• InjuryJun 23, 2020Break

  IT WAS REPORTED THE DURING A LEFT FOOT HAMMERTOE 2ND METATARSAL PROCEDURE THE HAMMERTOE IMPLANT WAS IMPLANTED PER THE TECHNIQUE. UPON ADVANCING THE K-WIRE TO DEPLOY THE WINGS, THE K-WIRE SNAPPED WHILE IT WAS CROSSING THE MIDPOINT OF THE IMPLANT. WIRE WAS ADVANCED ON FORWARD, NOT ON OSCILLATE. THE IMPLANT ITSELF WAS GOOD, ONLY THE K-WIRE BROKE. A PIECE OF THE GUIDEWIRE WAS LEFT IN THE PATIENT'S TOE. PART/LOT INVOLVED: AR-4158DS-14S / LOT 10448924. PATIENT BONE QUALITY WAS NORMAL PER THE SURGEON.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10184287 ↗