NA 690.409Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982253415), received between Apr 29, 2021 and Apr 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 29, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(4) 2021, THERE WAS A DISCREPANCY ON THE LENGTHS OF A 3.5 CANNULATED SCREW. AFTER THE CASE, THIS WAS ADDRESSED BY THE STERILE PROCESSING STAFF AND EACH SCREW IN THE SET MEASURED 2MM LONGER THAN LISTED SIZE. STAFF ALSO TOOK ONE FROM A PACKAGE AND MEASURED IT ON THE LID AND IT MEASURED 2MM LONGER THAN PACKAGE LISTED. SCREW IN QUESTION IS A 30MM BUT ALMOST MEASURES A 32MM. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 3.5MM SCREW RACK FOR 3.5/4.0MM COMBINED CANNULATED SCREW SET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744444 ↗