NA 317.66Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587038650), received between Aug 22, 2022 and Aug 22, 2022 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 22, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING MANDIBULAR SSRO FOR TREATING JAW DEFORMITY, THE DRILL BIT IN QUESTION BROKE OFF WHILE IN USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS REPORT IS FOR A 1.5MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271410 ↗