NA 04.200.045Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982115829), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 9, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR TIBIAL PLATEAU FRACTURE. WHEN THE PRODUCT WAS OPENED THE INNER TUBE WAS LEFT INSIDE OF THE OUTER TUBE. A NURSE TILTED THE PRODUCT TO EXAMINE IT BUT CAUSED THE INNER TUBE TO BECOME UNCLEAN. THE PRODUCT IN QUESTION WAS NOT USED AND A REPLACEMENT WAS OPENED FOR USE IN THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT OR DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487716 ↗