Arthrex® AR-1938DSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867287389), received between Jan 30, 2023 and May 24, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Mechanical Jam; Mechanical Jam

  ON 11/4/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1938DSS SUTURETAK KIT'S DRILL BIT GOT STUCK IN THE GUIDE. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393375 ↗
• MalfunctionDec 7, 2023Melted; Melted

  ON 11/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1938DSS DISPOSABLE KITS DRILL GUIDE MELTED. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18286694 ↗
• MalfunctionJan 30, 2023Break; Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED ON 01/10/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1938DSS DISPOSABLES KIT DRILL SLEEVE COLD WELDED AND STARTED FLAKING OFF DURING PROCEDURE. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263404 ↗