Arthrex® AR-1938PKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867271647), received between Feb 13, 2020 and Jun 18, 2024 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1938PK PERC INSERT KIT HAD A DRILL BIT THAT WAS JAMMED IN THE DRILL SLEEVE. THIS OCCURRED ON (B)(6) 2023 AT AN UNSPECIFIED TIME WITHOUT ANY CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558633 ↗
• InjuryFeb 13, 2020Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE NITINOL WIRE BENT AND BROKE WHEN THE GUIDE WAS REMOVED FROM THE PATIENT. A PARTIAL WIRE, ABOUT 2" WAS LEFT IN THE PATIENT. THE PATIENT IS TO RETURN ON (B)(6) 2020 TO HAVE IT REMOVED. WENT TO TAKE THE GUIDE OUT AND IT BENT. THERE WAS NO REP IN THE CASE, PATIENT IS MALE; LABRUM CASE. ADDITIONAL INFORMATION OBTAINED 2/13/20: THE WIRE FRAGMENT WAS SUCCESSFULLY REMOVED ON (B)(6) 2020 WITH NO COMPLICATIONS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9706017 ↗