NA 2004-20-920Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295081012), received between Nov 7, 2017 and Feb 14, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE INTO TWO PIECES AT THE SPIKE HOUSING JUNCTION. NO SURGICAL DELAY AND NEEDS REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13523018 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT THE SPIKE BROKE OFF. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10770181 ↗
• MalfunctionMar 7, 2019Break; Break

  THE SPIKE OF THE FIXED REFERENCE GUIDE GOT STUCK IN THE CUTTING GUIDE AND WHEN TRYING TO REMOVE IT SHEARED OFF, LEAVING JUST ONE SPIKE LEFT AND THE INSTRUMENT BROKEN AND UNFIT FOR PURPOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8400493 ↗
• MalfunctionJan 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ONE OF THE PINS DETACHED FROM THE DRIVING PORTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7182725 ↗
• MalfunctionNov 7, 2017Break; Break

  IT WAS REPORTED THAT THE FIXED REFERENCE GUIDE BROKE INTRAOPERATIVELY.

  Patient problems: No Information

  MAUDE report 7007914 ↗