NA 1896-4030SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540202345), received between Apr 22, 2020 and Oct 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "A RADIOLUCENT DRILL BROKE, AND A SPARE DRILL WAS USED TO RESOLVE THE ISSUE.THE SCREW COULD NOT BE INSERTED INTO THE HOLE OF THE NAIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23204154 ↗
• MalfunctionJul 12, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED: "DURING OPENING OF THE SCREW PACKAGING A FOREIGN BODY WAS VISUALISED BY THE SCRUB NURSE, MYSELF AND THE SCOUT NURSE. THE SCREW AND FOREIGN BODY WERE REMOVED INTO A SPECIMEN JAR AND COLLECTED FOR RETURN TO STRYKER FOR INVESTIGATION. THERE WAS NO DELAY IN SURGERY AND NO IMPACT ON THE PATIENT AS THE SCREW WAS NOT IMPLANTED AND WAS QUARANTINED WITHIN A SEPARATE AREA OF THE ASEPTIC FIELD. A SECOND SCREW OF THE SAME SIZE WAS OPENED AND IMPLANTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306155 ↗
• MalfunctionApr 22, 2020Difficult to Insert; Difficult to Insert

  AS REPORTED: "WHEN THE PROXIMAL TARGET DEVICE WAS USED, THE DRILLING OF THE OBLIQUE HOLE WENT TO THE LONG DIRECTION, AND THE SCREW COULD NOT BE INSERTED." ADDITIONALLY REPORTED: "THE SCREW WAS REPORTED AS THE DEFECTIVE PRODUCT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9988796 ↗