AXSOS 705032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327083446), received between Jun 9, 2021 and Apr 2, 2025 — classified as 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Break; Fracture; Break; Fracture

  I WAS REPORTED THAT: "BROKEN DRILL DURING SURGERY."

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

  MAUDE report 21756309 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) HIP, TIP OF DRILL WAS BROKEN DURING SURGERY, IT WAS EMBEDDED IN THE BONE. THE SURGEON DECIDED TO KEEP THE BROKEN TIP IN SITU. NO HARM KNOWN TO PATIENT. IT AS FURTHER CLARIFIED IN A SURGEON NOTE THAT: ""PATIENT HAD RELATIVELY GOOD BONE QUALITY AND ALL SCREWS HAD EXCELLENT BITE". AT LEAST 6 CORTICAL SCREWS +LAG SCREW, THEN DRILLED AND PLACED MULTIPLE DISTAL FEMORAL LOCKING SCREWS AFTER LAGGING IN, THE REMAINING SCREWS WERE PLACED IN LOCKING MODE. A TOTAL OF 19 SCREWS IMPLANTED. TO NOT COMPROMISE THE STABILITY OF THE CONSTRUCTION AND REVISION FEMORAL STEM, DRILL BIT WAS RETAINED IN THE BEST INTEREST OF THE PATIENT. SITE CLOSED WITH STRATAFIX, SKIN CLOSED WITH STAPLES, STERILE DRESSING APPLIED."

  Patient problems: Foreign Body In Patient

  MAUDE report 11966798 ↗