In2Bones G01 01511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03760225715901), received between Feb 3, 2026 and Mar 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Product Quality Problem; Use of Device Problem

  3 BURRS WITH THE SAME BATCH RECORD BROKE. 2 BROKE IN PATIENTS' METATARSALS; 1 BROKE WHEN TAKEN OUT OF THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711249 ↗
• MalfunctionMar 26, 2026Use of Device Problem

  SURGERY: HALLUX VALGUS. USE OF A SHANNON BURR TO MAKE THE OSTEOTOMY ; THE BURR BROKE AT ITS EXTREMITY INTO THE BONE. THE SURGERY DURATION WAS INCREASED TO REMOVE THE PIECE OF BROKEN BURR. ANOTHER BURR WAS USED, THE BROKEN BURR WAS KEPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697830 ↗
• MalfunctionFeb 3, 2026No Apparent Adverse Event

  ITV DATE: (B)(6)2025. SURGEON: DR. (B)(6). PATIENT: MALE, 22 YEARS OLD. INCRIMINATED DEVICES AVAILABLE FOR ANALYSIS: SHANNON BURRS LG 20MM, DIAM 2.0MM X LENGTH 75MM; REF (B)(4); BATCH 2502104. INCIDENT: USE OF FOUR SHANNON BURRS, WHICH BROKE INSTANTLY UPON USE, LEAVING THE TIP IN THE BONE. A DECISION WAS MADE TO USE ANOTHER, SMALLER MODEL, LENGTH 12. CONSEQUENCE: INCREASED SURGICAL TIME AND TOURNIQUET TIME. (15 - 30 MINUTES). THE SURGEON CONFIRMED AFTER DISCUSSION THAT HE WAS ABLE TO REMOVE THE FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244643 ↗