NA 03.505.217Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587014012), received between Jul 20, 2017 and Jul 20, 2017 — 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 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.

• InjuryJul 20, 2017Break; Break

  IT WAS REPORTED DURING A RIGHT 5TH PHALANGE FRACTURE REPAIR ON (B)(6) 2017 THAT A SCREWDRIVER BLADE TIP BROKE OFF INTO A 1.5 MM VARIABLE LOCKING SCREW. IT WAS DURING THE INSERTION OF THE LOCKING SCREW (2ND SCREW), THE TIP OF THE T4 TORX SCREWDRIVER BLADE BROKE OFF INTO THE HEAD OF THE SCREW. THE FIRST 1.5MM CORTEX SCREW HAD BEEN INSERTED WITHOUT INCIDENT. THE SURGEON ATTEMPTED REMOVAL OF THE BROKEN SCREWDRIVER TIP. THE SURGEON TRIED USING THE SYNTHES UNIVERSAL SCREW REMOVAL SET AND WAS UNABLE TO GRAB THE FRAGMENT BECAUSE THE HEAD OF THE SCREW CONTAINED THE BROKEN SCREWDRIVER TIP AND THE SCREW COULD NOT BE BACKED OUT. A SECOND SCREW REMOVAL SET WAS ALSO USED TO TRY AND REMOVE THE FRAGMENT BUT WAS UNSUCCESSFUL IN REMOVAL. THERE WAS A SURGICAL DELAY OF 1 HOUR WAS NOTED. THE SURGICAL DELAY WAS CAUSED BY TRYING TO LOCATE ANOTHER T4 TORX SCREWDRIVER BLADE AND FIVE (5) MINUTES OF THE DELAY WAS FROM THE ATTEMPTED SCREW REMOVAL. ANOTHER T4 SCREWDRIVER WAS NOT AVAILABLE AND THE SURGEON HAD TO SWITCH FROM THE 1.5MM VA LOCKING SCREWS TO THE 2.0MM CORTEX SCREWS (NON-LOCKING) AND USED THE T6 SCREWDRIVER FOR SCREW INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING 2.0 MM CORTEX SCREWS.

  Patient problems: Sedation

  MAUDE report 6729138 ↗