NA 03.130.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982257765), received between Jul 22, 2022 and Jul 9, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE TIME OF DRILLING THE DRILL BIT BROKE OFF. THE BROKEN BIT ALONG WITH ITS FRAGMENTS WERE REMOVED AND ANOTHER BIT OF THE SAME DIAMETER AND OF THE SAME CHARACTERISTICS WAS USED TO FINISH THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT IMPACT AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461676 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THREE 0.8 DRILL BITS AND ONE 1.0 DRILL BIT FROM THE 1.3 COMPACT HAND SYSTEM WERE BROKEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753386 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED ON APRIL 11, 2024 INTRA-OPERATIVELY A DRILL BIT BROKE DURING DRILLING. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19250141 ↗
• InjuryApr 4, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THE DRILL BIT IS BROKEN AND A PIECE OF IT REMAINS IN THE PATIENT'S BONE, THE SPECIALIST REPORTS THAT IT DOES NOT POSE A RISK TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DRILL BIT Ø0.8 L64/33 F/CORE HOLE THIS IS REPORT 1 OF 1 FOR COMPLAINT #:(B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16674070 ↗
• MalfunctionJul 22, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AT THE BEGINNING OF THE SURGERY, DURING INSPECTION OF THE DEVICE IT WAS IDENTIFIED THAT ONE OF THE 0.8 DIAMETER DRILL BITS WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 0.8MM DRILL BIT/K-WIRE ATTACH FOR THREADED HOLE/64MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15088335 ↗