NA 310.141Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982185983), received between Dec 18, 2017 and Jun 9, 2022 — classified as 2 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SINGAPORE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS WERE NOT RUNNING STRAIGHT. THE DRILL BITS WERE NEW AND HAD NOT BEEN USED ON A PATIENT. OTHER DRILL BITS WERE USED DURING THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) 1.5MM DRILL BIT/MINI QC/65MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14647007 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SINGAPORE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS WERE NOT RUNNING STRAIGHT. THE DRILL BITS WERE NEW AND HAD NOT BEEN USED ON A PATIENT. OTHER DRILL BITS WERE USED DURING THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) 1.5MM DRILL BIT/MINI QC/65MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14646991 ↗
• InjurySep 14, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING THE PROCEDURE, THE TIP OF THE 1.5MM DRILL BIT BROKE. FRAGMENTS WERE GENERATED AND A FRAGMENT REMAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DRILL BIT. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MINI QC/65MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12468184 ↗
• InjuryDec 18, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RADIUS ON (B)(6) 2017, 1.5MM DRILL BIT / MINI BROKE. THE FRAGMENT STILL REMAINS IN THE PATIENT. THERE IS NO REPORT OF SURGICAL DELAY OR PATIENT HARM. SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 2.0MM TITANIUM CORTEX SCREW SELF-TAPPING 14MM (401.814.96, LOT UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7126635 ↗