Arthrex® AR-1938DSRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867269064), received between Sep 18, 2019 and Sep 18, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2019Material Fragmentation

  IT WAS REPORTED DURING A SHOULDER ARTHROSCOPY WITH LABRAL REPAIR PROCEDURE THE AR-1938DSR SHAVERDRILL 3.0 MM SUTURETAK SHED METAL SHAVINGS ALL OVER WHILE BEING USED FOR INSERTION OF AR-1938BC. THE REP STATED THE SHAVERDRILL WAS BEING USED FOR BONE PREPARATION FOR INSERTION OF A QUANTITY TWO AR-1938BC, AND THE DEVICE SHED BOTH TIMES. THE SURGEON WAS ABLE TO CLEAN OUT THE METAL SHAVINGS WITH THE SHAVER, AND THE CASE WAS COMPLETED AS PLANNED. HOWEVER, IT CANNOT BE CONFIRMED IF ALL METAL SHAVINGS WERE FULLY REMOVED. THE REP STATED THE CASE WAS COMPLETED WITHOUT ADDING SIGNIFICANT TIME TO THE PROCEDURE, AND WITHOUT COMPROMISING PATIENT SAFETY. THE SHAVERDRILL WAS USED WITH THE AR-1946 DURABLE DRILL GUIDE. THE BONE QUALITY WAS MEDIUM, AND THE FLOW OF IRRIGATION WAS NOT INTERRUPTED DURING USE. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNING FOR EVALUATION. THERE ARE NO AVAILABLE PICTURES. DUALWAVE INFLOW BEING USED WAS AR-6410 (LOT: 33699482), AND OUTFLOW AR-6430 (LOT: 33955737).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9081272 ↗