NA 311.66Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982187505), received between Oct 1, 2021 and Sep 10, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionSep 10, 2026Break

  It was reported that it was broken with a small chip in the thread. There was no reported patient or user harm with no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713576 ↗
• InjuryOct 1, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE USING A 6.5MM TAP FOR CANCELLOUS BONE SCREWS IN THE ULNAR SHAFT PREPARING FOR FIXATION OF AN OLECRANON OSTEOTOMY THE THREADED PORTION OF THE 6.5MM TAP BROKE OFF IN THE MEDULLARY CANAL OF THE ULNA. THE SURGEON WAS UNABLE TO RETRIEVE THE FRAGMENT, IT WAS LEFT IN THE ULNA. THE OSTEOTOMY WAS FIXED USING A PLATE INSTEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A TAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12562404 ↗