NA 210439Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010102560), received between May 31, 2017 and Aug 11, 2023 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K093047); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A BILATERAL TENDON REPAIR SURGERY, WHILE SURGEON WAS DRILLING INTO PATIENTS LEFT PATELLA, THE TWIST DRILL 2.0MM BROKE OFF. THE SURGEON WAS NOT ABLE TO RETRIEVE THE DRILL BIT DESPITE TRYING TO REMOVE IT. SURGICAL TEAM DISCUSSED FOREIGN OBJECT RETENTION; AS THE DEVICE IS STERILE DRILL BIT, SURGEON WAS NOT CONCERNED AND SPOKE WITH THE FAMILY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17513684 ↗
• MalfunctionDec 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A RIGHT MID-FOOT FUSION, A TWIST DRILL 2.0MM BROKE WHILE IN USE. IT IS UNKNOWN HOW THE PIECES WERE REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED AND IF IT WAS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948857 ↗
• MalfunctionNov 17, 2022Break

  SMITH AND NEPHEW DRILL BIT 2.0 USED ON OPERATIVE FIELD BROKE WHILE IN USE. DEVICE REMOVED FROM FIELD. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814756 ↗
• InjurySep 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A RIGHT PATELLA TENDON REPAIR, THE TWIST DRILL 2.0MM BROKE. ALL PIECES WERE RECOVERED AND TAKEN AWAY FROM THE SURGICAL FIELD. X-RAY WAS TAKEN AND SHOWED NO FOREIGN OBJECT ON THE PATIENT. PROCEDURE WAS FINISHED WITHOUT FURTHER INCIDENT. PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519198 ↗
• MalfunctionSep 7, 2022Break

  DURING THE PROCEDURE A DRILL BIT BROKE. ALL PIECES WERE RECOVERED AND TAKEN AWAY FROM THE SURGICAL FIELD. X-RAY WAS TAKEN PER POLICY. RADIOLOGIST PHONED INTO ROOM, REPORTED DIRECTLY TO SURGEON, NO FOREIGN OBJECT. PROCEDURE WAS FINISHED WITHOUT FURTHER INCIDENT. PATIENT DISCHARGED TO PACU. DRILL BIT PIECES GIVEN TO SUPERVISOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369559 ↗
• MalfunctionOct 2, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY WHEN THE SURGEON WAS DRILLING THE PATIENT´S BONE THE TIP OF THE DRILL BIT BROKE OFF. BOTH PIECES WERE RECOVERED. X RAY WAS COMPLETED AND CONFIRMED THERE WERE NO PIECES LEFT IN THE PATIENT´S WOUND. IT IS UNKNOWN IF THERE WAS A DELAY OR A BACKUP DEVICE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9147999 ↗
• MalfunctionAug 23, 2019Break

  SURGEON WAS DRILLING PATIENTS BONE IN PATIENTS RIGHT FOOT WHEN THE TIP OF THE DRILL BIT BROKE OFF. BOTH PIECES WERE OBTAINED. IMAGING WAS COMPLETED AND CONFIRMED THERE WERE NO PIECES OF THE DRILL BIT LEFT IN THE PATIENT'S WOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925813 ↗
• InjuryMay 31, 2017Fracture; Fracture

  IT WAS REPORTED DURING SURGERY A PORTION OF DRILL BIT BROKE OFF IN THE PATIENT RIGHT SIDE. (2.0 DRILL BIT APPROX. 2.2 CM). AN X-RAY WAS OBTAINED PER PHYSICIAN. IT WAS DETERMINED THAT THE DRILL BIT WAS IN THE BONE AND NOT GOING TO MIGRATE THEREFORE IT WOULD BE LEFT IN AND NOT REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6601507 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434