CoLag P06 S0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810021866086), received between Jan 10, 2022 and Mar 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionMar 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A CANNULATED DRILL BROKE OFF WHILE DRILLING. THE SURGEON WAS UNABLE TO FULLY REMOVE THE DRILL AND THE PATIENT'S MEDIAL MALLEOULUS BROKE WHILE ATTEMPTING TO REMOVE THE DRILL. THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH K-WIRES. THE DHR REVIEW CONFIRMED THAT THE SINGLE-USE, STERILE DRILL WAS MANUFACTURED TO SPECIFICATIONS.

  Patient problems: Bone Fracture(s)

  MAUDE report 21644151 ↗
• MalfunctionJan 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A MIDFOOT FUSION PROCEDURE, THE 2.7 MM CANNULATED DRILL WAS PLACED OVER THE 0.062 " X 6 " GUIDE WIRE FROM THE SINGLE-USE INSTRUMENT KIT. THE DISTAL PORTION OF THE DRILL AND WIRE BROKE OFF AND WERE LEFT INSIDE THE PATIENT. THEY WERE UNABLE TO BE RETRIEVED. DEVICE HISTORY RECORDS WERE REVIEWED, AND THEY SHOWED THE DEVICES WERE MANUFACTURED TO SPECIFICATIONS. THE INSTRUMENTATION WAS DISCARDED POST-OP, SO THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. THE SURGEON STATED THERE WAS NO INTERFERENCE OR ANOMALIES FELT DURING THE DRILLING OR USE OF THE WIRE. AT THE TIME OF THE INCIDENT, NO OTHER HARDWARE WAS IN THE PATIENT. IT WAS ESTIMATED BY THE SURGEON THE DRILL WAS ABOUT 1 CM DEEP IN THE BONE AT THE TIME OF THE FRACTURE. NO KNOWN PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13212646 ↗