PATHWAY 2178-42-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295094876), received between Oct 3, 2017 and Nov 5, 2018 — 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.

• MalfunctionNov 5, 2018Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  THE DRILL PIN (B)(4) THAT WAS USED TO TEMPORARILY HOLD THE A/P FEMORAL RESECTION GUIDE TO THE DISTAL FEMUR BROKE IN HALF LEAVING PART OF THE DRILL PIN ENGAGED IN THE DISTAL FEMUR. THERE WAS NO SURGICAL DELAY FOR THIS CASE AND THERE WAS NO SURGICAL/MEDICAL INTERVENTION REQUIRED - AND THE INITIAL PLAN FOR THE TOTAL KNEE ARTHOPLASTY WAS NOT CHANGED. IN THE TIME OF THE CASE, I DID NOT SEE ANY ADVERSE IMPACT TO THE PATIENT. THERE WAS ANOTHER INSTRUMENT READILY AVAILABLE FOR USE. THE CONDITION OF THE PATIENT FOLLOWING THE PROCEDURE WAS STABLE. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039444 ↗
• MalfunctionOct 10, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  DRILL BIT SPLIT CROSSWISE AFTER IT WAS PLACED TO REST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951888 ↗
• MalfunctionOct 3, 2017Break; Break

  IT WAS REPORTED THAT ON COMPLETION OF THE CASE, DURING THE SWAB AND INSTRUMENT COUNT, SCRUB NURSE DA SOUZA NOTICED THAT ONE OF THE USED FIXATION DRILL PINS WAS NOT COMPLETELY INTACT. THERE WAS APPROXIMATELY 1CM FROM THE TIP OF THE PIN MISSING. IT WAS ALSO REPORTED THAT THE REMAINING PART OF THE DRILL BIT WAS NOTICED ON X-RAY FIXED ON THE MEDIAL SIDE OF THE FEMUR.

  Patient problems: Foreign Body In Patient

  MAUDE report 6911104 ↗