NA 03.226.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982077165), received between Mar 31, 2022 and Oct 6, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2022Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE HOLLOW PART OF CANNULATED TAP IN THE HEADLESS COMPRESSION SCREWS SET HAD DIRT ON IT. IT WAS CONFIRMED WHEN IT WAS CHECKED BEFORE DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE CANNULATED TAP FOR 4.5MM HEADLESS COMPRESSION SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552186 ↗
• MalfunctionMar 31, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY. BEFORE SURGERY, AN OPERATION STAFF CHECKED THE PRODUCTS IN QUESTION AND FOUND THAT THERE WERE DIRT/WATER DROPS-LIKE-RESIDUES IN THE HOLLOW PART OF EACH PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13958368 ↗