NA 04.205.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982116314), received between Jun 21, 2023 and Jun 21, 2023 — classified as 2 injuries.

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.

• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AFTER SURGERY THE INFECTION WAS FOUND, AND THE PATIENT WAS STARTED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN ORIF SURGERY FOR PLATEAU FRACTURE OF PROXIMAL LEFT TIBIA ON (B)(6) 2023. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. INFECTION WAS SEEN ON THE LATERAL AND MEDIAL SIDES OF THE PROXIMAL TIBIA. THE PATIENT WILL BE MONITORED WITH ANTIBIOTICS TO PRIORITIZE BONE-UNION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.0MM TI CANNULATED LOCKING SCREW 25MM. THIS IS REPORT 4 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17169631 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AFTER SURGERY THE INFECTION WAS FOUND, AND THE PATIENT WAS STARTED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN ORIF SURGERY FOR PLATEAU FRACTURE OF PROXIMAL LEFT TIBIA ON (B)(6) 2023. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. INFECTION WAS SEEN ON THE LATERAL AND MEDIAL SIDES OF THE PROXIMAL TIBIA. THE PATIENT WILL BE MONITORED WITH ANTIBIOTICS TO PRIORITIZE BONE-UNION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.0MM TI CANNULATED LOCKING SCREW 25MM. THIS IS REPORT 2 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17169610 ↗