Arthrex® AR-4159-16DRecalls & reported problems
Arthrex, Inc. · DYNANITE 1.6 DBL TIP NITI G-WIRE 2 ZONE · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867334908), received between Apr 28, 2023 and May 2, 2024 — classified as 3 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Sparking1
Patient problems
- Failure of Implant1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2024Break; Break
ON 3/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4159-16D DYNANITE 1.6 DBL TIP NITI G-WIRE BROKE POST OP INSIDE A PATIENT RIGHT FOOT. THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2022. CURRENTLY, THE BROKEN G-WIRE REMAINS IN THE PATIENT. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19230353 ↗MalfunctionJan 25, 2024Break; Break
ON 3/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A FLEXWIRE BROKE PROXIMALLY INSIDE THE PATIENT POST-OPERATIVE. THIS OCCURRED WHILE THE PATIENT WAS IN A CAST, WALKING ON IT. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/14/2023: THIS WAS DISCOVERED POST-OPERATIVE OF A HAMMER TOE PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT WAS BANDAGED AND PLACED IN A WALKING CAST WHEN ON (B)(6) 2023, THE FLEXWIRE BROKE. REVISION SURGERY HAS NOT BEEN SCHEDULED.
Patient problems: Failure of Implant
MAUDE report 18579162 ↗MalfunctionApr 28, 2023Sparking; Sparking
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4159-16D FLEXWIRE GENERATED A SPARK WHEN THE SURGEON ATTEMPTED TO CUT IT. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16837423 ↗
Other PIN, FIXATION, SMOOTH devices
- RIGIDFIX 210133Medos International Sàrl · PIN, FIXATION, SMOOTH91 reports
- SMART TOE ST0A-16PStryker GmbH · PIN, FIXATION, SMOOTH1 recall5 reports
- SMART TOE ST0-19PStryker GmbH · PIN, FIXATION, SMOOTH1 recall2 reports
- HammerTube™ System P40-002-0275-SParagon 28, Inc. · PIN, FIXATION, SMOOTH1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.