NA 02.130.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982044174), received between Oct 2, 2018 and Oct 2, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN OPEN REDUCTION OF INTERNAL FIXATION (ORIF) OF A METACARPAL FRACTURE PROCEDURE, WHEN THE SURGEON DOING THE FINAL TIGHTENING OF THE TWO (2) CORTEX SCREWS, THE HEADS OF THE SCREWS RIPPED OFF WHEN PROVIDING TENSION ON THE SCREW TO SUCK IT DOWN TO THE PLATE. THE DRILL BIT WAS ALSO BROKEN. THE PART OF A BROKEN DRILL BIT AND TWO OF THE CORTEX SCREW HEADS WERE REMOVED AND WHILE THE OTHER PARTS OF THE BROKEN SCREWS AND DRILL BIT WERE LEFT IN THE PATIENT. FRAGMENTS FROM BROKEN DEVICES WERE SUCCESSFULLY REMOVED. THERE WAS A 20-MINUTE SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART, LOT, & QUANTITY IS UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7926458 ↗
• MalfunctionOct 2, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN OPEN REDUCTION OF INTERNAL FIXATION (ORIF) OF A METACARPAL FRACTURE PROCEDURE, WHEN THE SURGEON DOING THE FINAL TIGHTENING OF THE TWO (2) CORTEX SCREWS, THE HEADS OF THE SCREWS RIPPED OFF WHEN PROVIDING TENSION ON THE SCREW TO INSERT IT IN THE PLATE. IN ADDITION, THE DRILL BIT ALSO BROKE. PART OF THE BROKEN DRILL BIT AND TWO OF THE CORTEX SCREW HEADS WERE REMOVED AND THE OTHER PARTS OF THE BROKEN SCREWS AND DRILL BIT WERE LEFT IN THE PATIENT. FRAGMENTS FROM BROKEN DEVICES WERE SUCCESSFULLY REMOVED. THERE WAS A 20-MINUTE SURGICAL DELAY. THE PATIENT'S OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART, LOT, & QUANTITY IS UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7926448 ↗