AXSOS 705025SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327083439), received between Feb 20, 2019 and Feb 2, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 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.

• MalfunctionFeb 2, 2026Fracture; Mechanical Jam

  AS REPORTED: "THE DRILL GOT STUCK IN THE SLEEVE AND BROKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235391 ↗
• InjurySep 16, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRILL BIT BROKE DURING DRILLING AND REMAINED INSIDE THE BODY. THE DRILLS HAD BEEN REUSED."

  Patient problems: Foreign Body In Patient

  MAUDE report 23068196 ↗
• MalfunctionAug 25, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TAP TIP BROKE OFF AND COULD NOT BE REMOVED. THE PROCEDURE WAS TERMINATED WITH THE TAP TIP REMAINING IN THE PATIENT'S BONE. IN SAME PROCEDURE, THE DRILL BIT WAS BROKEN. ALL DEBRIS WERE REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22888978 ↗
• MalfunctionAug 15, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE 705025S DRILL (2.5 MM) BROKE OFF. THE TIPI OF THE DRILL WAS RETRIEVED FROM INSIDE THE PATIENT'S BONE. BACKUP DEVICES HAD TO BE USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822206 ↗
• MalfunctionAug 18, 2022Break; Fracture; Break; Fracture

  IT IS REPORTED A DRILL BIT HAS "BROKEN". ADDITIONAL INFORMATION RECEIVED: THE SURGERY WAS COMPLETED SUCCESSFULLY BY OPENING A NEW DRILL. THERE WAS A SLIGHT DELAY IN THE SURGERY AS A CONSEQUENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255092 ↗
• MalfunctionFeb 4, 2020Fracture; Fracture

  IT WAS REPORTED, AFTER AXSOS DF SURGERY, IT WAS FOUND THAT THE TIP OF THE DRILL BIT WAS REMAINED TO THE PATIENT BY X-RAYS. THE SURGEON DID NOT NOTICE THE DRILL BREAKAGE DURING THE SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9667673 ↗
• MalfunctionJun 24, 2019Break; Mechanical Jam

  THE CUSTOMER REPORTED THAT THE SURGEON WAS OPERATING ON A DISTAL MEDIAL TIBIA AND THAT WHEN USING THE 2.5MM DRILL 705025S IT SNAPPED INSIDE THE DRILL SLEEVE AND BECAME STUCK. THERE WERE NO ADVERSE EVENTS OR SURGICAL DELAYS. THE SURGEON OPENED ANOTHER SET TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729052 ↗
• MalfunctionFeb 20, 2019Break

  IT WAS REPORTED THAT WHEN THE DRILL BIT WAS BROKEN DURING DRILLING. THEREFORE, IT WAS CHANGED THE NEW SAME ONE AND THE OPERATION WAS SUCCEEDED. ALL BROKEN PIECE WAS REMOVED FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8356290 ↗