Arthrex® AR-16991NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867189362), received between Feb 28, 2018 and May 18, 2021 — 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.

• MalfunctionMay 18, 2021Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR, THE TIP OF THE AR-16991N BROKE OFF WHEN PASSING SUTURE; IT WAS NOT RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED; THE PATIENT IS A (B)(6) FEMALE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11842611 ↗
• InjuryFeb 28, 2018Break; Device Or Device Fragments Location Unknown

  IT WAS REPORTED VIA FACILITY SUBMITTED MEDWATCH REPORT (0733000000-2018-8012) THAT IN JANUARY 2018 (SPECIFIC DATE NOT PROVIDED) THE DOCTOR WAS PERFORMING A HIP ARTHROSCOPY ON A PATIENT. AS HE INSERTED THE ARTHREX SCORPION NEEDLE, HE NOTED THAT THE TIP HAD BROKEN OFF OF THE NEEDLE. NEEDLE WAS REMOVED AND X-RAYS WERE OBTAINED WITH C-ARM. THE NEEDLE TIP WAS NOT VISUALIZED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7302194 ↗