NA 400.528Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982203434), received between Aug 30, 2023 and Aug 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 30, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2023, THAT THE SURGEON SAID THAT WHILE USING A MODULAR HAND 1.0MM SCREW IN A FINGER CASE EARLIER THIS WEEK, UPON IMPLANTATION, THE SCREW HEAD BROKE OFF. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE RETAINED IN THE PATIENT AND WERE NOT REMOVED. THERE WERE NO PATIENT-ADVERSE EVENTS OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.0MM TI CORTEX SCREW SELF-TAPPING 8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650889 ↗