PIPELINE 288205052Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034220529), received between Mar 21, 2018 and Sep 14, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  It was reported that during the surgery, noted the device was broken off. Another device was used to complete the surgery. There were no adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753129 ↗
• MalfunctionOct 11, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY, NO OTHER MEDICAL INTERVENTION, IT DID NOT BREAK INTO TWO OR MORE PIECES, AND NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429403 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER ORDERED OSTEOTOMES, AND THEY WERE RECEIVED BROKEN. THESE WERE BOTH ORDERED IN LOOSE GOODS AND CAME AS BRAND NEW. HOWEVER, BOTH HAD ROUGH JAGGED EDGES NOT SUITABLE FOR SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE PIPELINE ACCESS SYSTEM OSTEOTOME, STRAIGHT 8MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929799 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER ORDERED OSTEOTOMES, AND THEY WERE RECEIVED BROKEN. THESE WERE BOTH ORDERED IN LOOSE GOODS AND CAME AS BRAND NEW. HOWEVER, BOTH HAD ROUGH JAGGED EDGES NOT SUITABLE FOR SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE PIPELINE ACCESS SYSTEM OSTEOTOME, STRAIGHT 8MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929798 ↗
• MalfunctionMar 21, 2018Break; Material Fragmentation; Break; Material Fragmentation

  THE OSTEOTOME LOOKS VERY WORN AND CHIPPED DUE TO LOTS OF USE AND NEEDS TO BE REPLACED. 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 7359586 ↗