Arthrex® AR-4159-11DRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867334892), received between Jan 11, 2021 and May 21, 2024 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE AR-4159-11D WIRE THAT IS SUPPOSED TO BE BENDABLE WOULDN¿T STAY BENT, AS IT WAS SUPER ELASTIC. THE CASE WAS COMPLETED BY USING A NEW AR-4159-11D.

  Patient problems: Insufficient Information

  MAUDE report 19357706 ↗
• InjuryNov 22, 2023Break; Break

  ON 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06066780 THAT AN AR-4159-11D FLEXWIRE BROKE TWO WEEKS POST-OPERATION. ON (B)(6) 2023, A PATIENT UNDERWENT A SECOND AND THIRD HAMMERTOES PROCEDURE IN WHICH AN AR-4158DS-12S DYNANITE PIP WAS IMPLANTED ALONG WITH THE FLEXWIRE. TWO WEEKS LATER, DURING A POST-OPERATION VISIT, IT WAS CONFIRMED THAT THE FLEXWIRE AT THE SECOND MTP JOINT WAS BROKEN; THE THIRD WIRE WAS INTACT. BOTH WIRES WERE REMOVED DURING THE OFFICE VISIT.

  Patient problems: Failure of Implant

  MAUDE report 18195212 ↗
• InjuryNov 22, 2023Break; Break

  ON 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4159-11D FLEXWIRE BROKE TWO WEEKS POST-OPERATION. ON 6/22/2023, A PATIENT UNDERWENT A SECOND AND THIRD HAMMERTOES PROCEDURE IN WHICH AN AR-4158DS-12S DYNANITE PIP WAS IMPLANTED ALONG WITH THE FLEXWIRE. TWO WEEKS LATER, DURING A POST-OPERATION VISIT, IT WAS CONFIRMED THAT THE FLEXWIRE AT THE SECOND MTP JOINT WAS BROKEN; THE THIRD WIRE WAS INTACT. BOTH WIRES WERE REMOVED DURING THE OFFICE VISIT.

  Patient problems: Insufficient Information

  MAUDE report 18194240 ↗
• MalfunctionNov 22, 2023Break; Break

  ON 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06066780 THAT AN AR-4159-11D FLEXWIRE BROKE TWO WEEKS POST-OPERATION. ON (B)(6) 2022, A PATIENT UNDERWENT A SECOND AND THIRD HAMMERTOES PROCEDURE IN WHICH AN AR-4158DS-12S DYNANITE PIP WAS IMPLANTED ALONG WITH THE FLEXWIRE. TWO WEEKS LATER, THE PATIENT KICKED A BRANCH WHEN WALKING THROUGH THE WOODS. DURING THE POST-OPERATION VISIT, IT WAS CONFIRMED THAT THE FLEXWIRE AT THE SECOND MTP JOINT WAS BROKEN; THE THIRD WIRE WAS INTACT. BOTH WIRES WERE REMOVED DURING THE OFFICE VISIT.

  Patient problems: Insufficient Information

  MAUDE report 18192444 ↗
• InjuryNov 22, 2023Break; Break

  ON 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06066780 THAT AN AR-4159-11D FLEXWIRE BROKE TWO WEEKS POST-OPERATION. ON (B)(6) 2023, A PATIENT UNDERWENT A SECOND AND THIRD HAMMERTOES PROCEDURE IN WHICH AN AR-4158DS-12S DYNANITE PIP WAS IMPLANTED ALONG WITH THE FLEXWIRE. TWO WEEKS LATER, DURING A POST-OPERATION VISIT, IT WAS CONFIRMED THAT THE FLEXWIRE AT THE SECOND MTP JOINT WAS BROKEN; THE THIRD WIRE WAS INTACT. BOTH WIRES WERE REMOVED DURING THE OFFICE VISIT.

  Patient problems: Failure of Implant

  MAUDE report 18190146 ↗
• InjuryNov 21, 2023Break; Break

  ON 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06066780 THAT AN AR-4159-11D FLEXWIRE BROKE TWO WEEKS POST-OPERATION. ON 6/22/2023, A PATIENT UNDERWENT A SECOND AND THIRD HAMMERTOES PROCEDURE IN WHICH AN AR-4158DS-12S DYNANITE PIP WAS IMPLANTED ALONG WITH THE FLEXWIRE. TWO WEEKS LATER, DURING A POST-OPERATION VISIT, IT WAS CONFIRMED THAT THE FLEXWIRE AT THE SECOND MTP JOINT WAS BROKEN; THE THIRD WIRE WAS INTACT. BOTH WIRES WERE REMOVED DURING THE OFFICE VISIT.

  Patient problems: Insufficient Information

  MAUDE report 18184366 ↗
• MalfunctionNov 21, 2023Break; Break

  ON 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4159-11D FLEXWIRE BROKE TWO WEEKS POST-OPERATION. ON (B)(6) 2022, A PATIENT UNDERWENT A SECOND AND THIRD HAMMERTOES PROCEDURE IN WHICH AN AR-4158DS-12S DYNAMITE PIP WAS IMPLANTED ALONG WITH THE FLEXWIRE. TWO WEEKS LATER, THE PATIENT KICKED A BRANCH WHEN WALKING THROUGH THE WOODS. DURING THE POST-OPERATION VISIT, IT WAS CONFIRMED THAT THE FLEXWIRE AT THE SECOND MTP JOINT WAS BROKEN; THE THIRD WIRE WAS INTACT. BOTH WIRES WERE REMOVED DURING THE OFFICE VISIT.

  Patient problems: Insufficient Information

  MAUDE report 18184359 ↗
• InjuryNov 28, 2022Break

  ON 11/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-4159-11D DYNANITE FLEXWIRE WAS FOUND BROKEN DURING A POST OPERATION OFFICE VISIT ON (B)(6) 2022. THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 11/11/2022: SURGEON REMOVED THE FLEXWIRE, REVISION SURGERY IS DATE UNKNOWN AT THIS TIME. ORIGINAL PROCEDURE WAS PERFORMED DUE TO A HAMMERTOE CORRECTION AND PERFORMED BY THE SAME SURGEON, AS WELL AS THE SAME FACILITY. ADDITIONAL INFORMATION RECEIVED ON 11/14/2022: DURING THE POST-OPERATION OFFICE VISIT ON (B)(6) 2022, SURGEON FOUND THAT THE FLEXWIRE WAS BROKEN, AND IT WAS EXPLANTED IMMEDIATELY IN THE OFFICE.

  Patient problems: Failure of Implant

  MAUDE report 15868861 ↗
• InjurySep 19, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4159-11D DYNANITE WIRE BROKE AFTER BEING IMPLANTED, LEADING TO A REVISION SURGERY. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15445608 ↗
• InjuryJan 11, 2021Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A HAMMERTOE CORRECTION PROCEDURE. SIX WEEKS POST OP IT WAS DISCOVERED THAT THE IMPLANT DEVICE BROKE. THE PATIENT IS A 76 YEAR OLD FEMALE. AT TIME OF INITIAL REPORT THE SPECIFIC ARTHREX PART NUMBER WAS UNKNOWN AND SURGEON DOES NOT HAVE IMMEDIATE PLANS TO REMOVE THE DEVICE. ADDITIONAL INFORMATION OBTAINED 12/24/2020; SALES REP CALLED WITH PART NUMBER AR-4159-11D. ADDITIONAL INFORMATION OBTAINED 1/5/2021: THE PATIENT HAS CONFIRMED THAT THE END OF THE AR-4159-11D THAT EXTRUDES FROM THE END OF THE TOE WAS ABLE TO BE PULLED OUT BY THE SURGEON IN HIS CLINIC. THIS PORTION OF THE WIRE WILL BE RETURNED TO ARTHREX FOR EVALUATION. THE REMAINING PORTION OF THE WIRE WAS LEFT IN THE PATIENT WITH NO PLANS TO EXPLANT IT UNLESS IT CAUSES THE PATIENT DISCOMFORT IN THE FUTURE. PATIENT STATES THE WIRE BEING BROKEN DOES NOT ALLOW FOR A FULLY SUCCESSFUL HAMMERTOE CORRECTION. ADDITIONAL TIMELINE INFORMATION OBTAINED FROM PATIENT'S SURGEON 1/11/2021: (B)(6) 2020: LEFT OPENING WEDGE PROXIMAL FIRST METATARSAL OSTEOTOMY, MODIFIED AKIN PROCEDURE, SECOND HAMMERTOE CORRECTION WITH METATARSOPHALANGEAL JOINT CAPSULOTOMY AND EXTENSOR TENDON LENGTHENING. SECOND HAMMERTOE WAS CORR

  Patient problems: Failure of Implant

  MAUDE report 11147047 ↗