NA 310.19SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982186119), received between Sep 5, 2025 and Sep 5, 2025 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Break; Entrapment of Device; Break; Entrapment of Device

  USER FACILITY REPORT RECEIVED (B)(4).IT WAS REPORTED THAT THE HCP HAD A PATIENT WITH A DISTAL TRICEPS TRAUMATIC RUPTURE. PATIENT WAS BROUGHT TO THE OPERATING ROOM. STANDARD FIXATION FOR THIS TYPE OF INJURY IS TO DRILL 2 PARALLEL TUNNELS THROUGH THE INSERTION POINT IN THE OLECRANON EXITING MORE DISTAL IN THE OLECRANON BONE AND REPAIRING THE TRICEPS WITH STITCHES AND A SECONDARY BACKUP CALLED A SWIVELOCK. SURGEON USED A 2 MM DRILL BIT, DRILLED THE 1ST HOLE WITHOUT ANY PROBLEM. WHILE DRILLING THE 2ND HOLE TRYING TO EXIT THE OUTER CORTEX THE DRILL BIT BROKE WHILE IN THE ULNA. INTRAOPERATIVE FLUOROSCOPY CONFIRMED THE INTRAMEDULLARY POSITION OF THE BROKEN DRILL BIT. THIS WAS NOT INTRA-ARTICULAR OR EXTRA-ARTICULAR. IT WAS INTRAMEDULLARY. THIS WAS THE APPROPRIATE POSITIONING OF THE DRILL HOLE. SURGEON ATTEMPTED TO RETRIEVE THE DRILL BIT WHICH WAS LODGED IN THE INTRAMEDULLARY CANAL OF THE ULNA BONE. MULTIPLE ATTEMPTS AT REMOVING THIS WITH INSTRUMENTS IN BOTH IN ANTEGRADE AND RETROGRADE FASHION WERE UNSUCCESSFUL. SURGEON TRIED CURETTING THE BONE AND RONGEURING THE BONE HOWEVER MY ATTEMPTS TO REMOVE THE BROKEN DRILL BIT JUST CREATED MORE BONY DESTRUCTION. IN ORDER TO REMOVE THIS BR

  Patient problems: Bone Notching; Foreign Body In Patient

  MAUDE report 22981687 ↗