NA 397.342Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982201034), received between Nov 4, 2020 and Jul 11, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE 5 BITS DO NOT CLICK INTO PLACE ON THE MOTOR'S QUICK-LOCK CHUCK. THIS REPORT INVOLVES ONE (1) 2.5MM DRILL BIT/JC/400MM 140MM CALIBRATION. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19719450 ↗
• InjuryNov 4, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING PELVIS FIXATION A 2.5MM DRILL TIP BROKE OFF IN THE PATIENT. THE TIP WAS NEVER ACCESSIBLE DUE TO THE DEPTH AT WHICH IT WAS INSERTED. THE CASE WAS TERMINATED. ACTION TAKEN WHEN THE EVENT OCCURRED FAILED RETRIEVAL. FRAGMENTS WERE GENERATED BUT WERE NOT REMOVED EASILY IT COULD NOT REACH THE TIP. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/JC/400MM 140MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10787324 ↗