Arthrex® AR-4158DS-16BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867310032), received between Jun 27, 2022 and Jun 27, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2022Material Twisted/Bent; Output Problem; Positioning Problem

  ON (B)(6) 2022, IT WAS REPORTED BY SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4158DS-16B DYNAMITE HAMMERTOE SCREW ENDED UP CHEWING AWAY AT THE BONE CANAL AND IT WAS NOT SECURE. SURGEON ANALYZED THE INSERTER AND REALIZED THE IMPLANT WAS PLACED ON THE INSERTER INCORRECTLY, THE BENT PORTION WAS FACING THE WRONG WAY. THIS DID NOT ALLOW THE SCREW TO BE INSERTED STRAIGHT, CAUSING THE FAILURE AT THE BONE CANAL DURING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 5/31/2022: THIS WAS DISCOVERED DURING A HAMMERTOE PROCEDURE AND COMPLETED WITH THE SAME AR-4158DS-16B DYNAMITE DEVICE BY INSERTING THE DYNAMITE HAMMERTOE PORTION AND USING A K-WIRE TO PIN THE TOE SINCE IT DESTROYED THE MIDDLE PHALANX DUE TO BEING ON THE INSERTER IN THE OPPOSITE DIRECTION. NOTHING BROKE INSIDE THE PATIENT AND NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14829197 ↗