Arthrex® AR-1949Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867024304), received between Jan 29, 2021 and Apr 25, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2022Break; Mechanical Jam

  IT WAS REPORTED THAT DURING POSTERIOR STABILIZATION SURGERY THE 3MM SHAVER DRILL GOT STUCK INSIDE THE DRILL GUIDE WHEN DRILLING INTO BONE AND BREAKS THE SHAVER DRILL HANDPIECE CONNECTOR. ORIGINALLY SWAPPED THE SHAVER DRILL BUT THE GUIDE DAMAGED THIS DRILL ALSO. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 14194550 ↗
• MalfunctionJan 29, 2021Material Fragmentation; Device Fell

  IT WAS REPORTED THAT SPEAR FOR 2.8 MM FASTAK, AR-1949, WAS BEING USED IN A BANKHART REPAIR. DURING USE, WHEN THE SURGEON DRILLED INTO THE GLENOID, PIECES OF METAL WERE GENERATED AND FELL INTO THE PATIENT'S BODY. THE SURGEON CLEANED INSIDE OF THE JOINT, BUT COULD NOT CONFIRM WHETHER ALL THE METAL PIECES WERE REMOVED. AR-1250FT WAS ALSO USED WHEN DRILLING. THE SURGERY WAS COMPLETED BY USING NEW PRODUCTS OF SAME PART NO.

  Patient problems: Foreign Body In Patient

  MAUDE report 11251314 ↗