NA 400.816.96Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982203793), received between Aug 22, 2019 and Aug 22, 2019 — classified as 1 injury.

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 18, 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.

• InjuryAug 22, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION OF A LEFT 4TH METACARPAL, THE 1.5MM TITANIUM CORTEX SCREW BROKE RIGHT BELOW THE HEAD OF THE SCREW UPON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF TWENTY-FIVE (25) MINUTES. THE BROKEN SCREW WAS REMOVED BY REAMING OVER THE TOP OF THE BROKEN SCREW SHAFT AND UNSCREWING WITH A HEAVY UNKNOWN NEEDLE DRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HARM TO THE PATIENT-REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE ( PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1), UNKNOWN SCREWS (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 1.5MM TI CORTEX SCREW 16MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8921737 ↗