NA 310.215Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982186225), received between Feb 12, 2018 and Nov 1, 2023 — classified as 2 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TPLO WAS BEING PERFORMED ON A CAT. WHEN DRILLING WITH THE BITS IN QUESTION, THE K-WIRE BECAME JAMMED. SURGERY WAS DELAYED FOR 15 MINUTES BUT WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. THIS REPORT IS FOR A 1.7MM CANNULATED DRILL BIT/QC 100MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047053 ↗
• InjuryMar 28, 2018Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT WHEN USING 2.4MM CANNULATED SCREW SET AND DRILLING OVER A 0.8MM GUIDE WIRE AND TAKING DRILL BIT OUT AFTER DRILLING, IT WAS NOTICED THAT THE TIP OF THE DRILL BIT HAD BROKEN OFF. FRAGMENTS OF THE DRILL BIT WERE LEFT IN PATIENT. ALSO DURING THIS FOOT PROCEDURE, ONE OF THE 0.8MM GUIDE WIRES WAS BENT DURING INSERTION OF A SCREW. THE BENT GUIDE WIRE WAS TAKEN OUT AND REPLACED WITH A NEW ONE. THERE WAS 5-7 MINUTES DELAY IN THE SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 2.4MM CANNULATED SCREW (PART 211.820, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 1.7MM CANNULATED DRILL BIT THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7379842 ↗
• InjuryFeb 12, 2018Break; Break

  IT WAS REPORTED THAT A 1.7MM CANNULATED DRILL BIT BROKE DURING A PODIATRIC PROCEDURE ON (B)(6) 2018. AS THE BIT WAS PASSED OVER THE GUIDE WIRE AFTER MEASURING FOR THE CANNULATED SCREW, THE BIT BROKE AND A PORTION WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT FURTHER INCIDENT. THAT PATIENT OUTCOME WAS REPORTEDLY SATISFACTORY. NO DELAY IN OPERATING ROOM TIME WAS REPORTED. CONCOMITANT DEVICES: CANNULATED SCREW (PART/LOT UNKNOWN, QUANTITY 1); GUIDE WIRE (PART/LOT UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7263284 ↗