IBS™ G01 00091Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03760225713105), received between Sep 19, 2025 and Mar 30, 2026 — classified as 3 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 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.

• MalfunctionMar 30, 2026Use of Device Problem

  THE K WIRE CAME OUT OF THE DRILL BIT CANNULA AND BECAME STUCK IN THE CANNULA WINDOW. THE SURGEON STOPPED THE MOTOR ROTATION BEFORE ANY FURTHER DAMAGE OCCURRED. ACCORDING TO THE OPERATOR, THE ADDITIONAL BARS ADDED TO THE DRILL BIT CANNULAS ARE CONSIDERED UNSAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725527 ↗
• MalfunctionSep 19, 2025Break; Break

  REFER TO F. FOGAROTTO (FROM THE DISTRIBUTOR COMPANY IN ITALIA) EMAIL DATED ON (B)(6) 2021: « WE HAVE A PROBLEM WITH 1.6MM DRILL REF. (B)(4). IN THE LAST PERIOD THESE DRILLS BREAK AT EACH SURGERY. I THOUGH IT WAS THE SURGEON'S MISTAKE, BUT WHEN I TOLD THEM TO BE CAREFUL, TO FOLLOW THE SURGICAL TECHNIQUE AND POSSIBLY GIVE ME FEEDBACK, THE DRILL BROKE AGAIN. THE DRILLS BROKE IN THE OPENED PART. I DON'T KNOW IF THE PROBLEM LIES IN THE DESIGN BUT I THINK YOU SHOULD GO DEEPER IN THAT. » ADDITIONAL INFORMATION RECEIVED BY E-MAIL ON NOVEMBER 17TH, 2021: « - YES, THE SURGERIES WERE COMPLETED WITHOUT ANY PROBLEMS. - NO, THERE WERE NO PARTICULAR CONDITIONS. 2 DIFFERENT SURGEON, 4 DIFFERENT PATIENTS, DIFFERENT AGES, DIFFERENT INDICATIONS, DIFFERENT IMPLANT SITE. - WE GOT ANOTHER BROKEN DRILL JUST YESTERDAY. HERE THE BATCH NUMBERS: 1809019, 1706211 (X2), 2101108. » "THE BROKEN DRILLS ARE NEW, NO SIGNS OF WEAR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095811 ↗
• MalfunctionSep 19, 2025Break; Break

  EVENT DESCRIPTION: PATIENT INITIALS CHA, MALE, AGED 61 YEARS, WEIGHT 78 KG. DURING THE USE (FOR A RIGHT SUBTALAR ARTHRODESIS), THE CANNULATED DRILL BROKE. IT WAS REMOVED FROM THE PATIENT, WITH THE K-WIRE STUCK INSIDE. NO CLINICAL CONSEQUENCES. THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

  Patient problems: Insufficient Information

  MAUDE report 23093999 ↗