NA 7207221Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010375322), received between Nov 19, 2018 and May 14, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE GUIDE WIRE BROKE OFF INSIDE THE TIBIA. SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE WHICH NOW REMAINS INSIDE PATIENT AND THE SURGEON DOES PLAN TO REMOVE IT LATER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE SINCE THIS WAS NOTICED AT THE END OF THE SURGERY. NO SIGNIFICANT DELAY AND NO OTHER COMPLICATIONS WERE REPORTED. CURRENTLY, THE PATIENT IS HAPPY, HEALTHY AND WITH NO PROBLEMS.

  Patient problems: Foreign Body In Patient

  MAUDE report 11828907 ↗
• MalfunctionNov 26, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE DRILL WAS FOUND TO BE DULL. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911720 ↗
• MalfunctionNov 19, 2018Material Deformation

  IT WAS REPORTED THAT DURING ACL PROCEDURE, DOCTOR OPENED AN ENDOBUTTON CL PAC AND AS THE CASE WENT ON AND HE USED THE 4.5MM DRILL TIP HE REALIZED THE 4.5 DRILL BIT LOOKED DIFFERENT THAN OTHERS HE HAD USED IN THE PAST. HE ASKED TO GET ANOTHER PAC TO COMPARE THE TWO, AND THEY WERE DIFFERENT. THE DRILL BIT OPENED FIRST, WAS LARGER AND HAD A DIFFERENT TIP THAN THE SECOND ONE. HE ENDED UP HAVING TO CREATE ANOTHER TUNNEL WITH THE NEW 4.5 DRILL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8087445 ↗