NA 219953Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705006991), received between Nov 20, 2019 and Nov 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE A PIECE OF BONE BECAME STUCK IN THE CHANNEL OF THE CUSTOMER'S PATHMAKER TUNNEL NOTCHER AND DURING CLEAN THEIR WERE UNABLE TO REMOVE IT FROM THE DEVICE. THE PROCEDURE HAD BEEN COMPLETED WITH THE DEVICE BEFORE THE ISSUE OCCURRED WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION OR A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS AN OLDER DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9350626 ↗