NA 02.130.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982044143), received between Jul 8, 2019 and Apr 16, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 29-MARCH-2024, THE SCREW DID NOT STAY ON THE SCREWDRIVER. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116937 ↗
• MalfunctionMar 28, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, TWO 1.3MM CORTEX SCREW HEAD BROKE OFF WHILE INSERTING INTO THE PLATE. THE SHAFTS OF THE SCREWS IN QUESTION REMAINED IN THE PATIENT, THE BROKEN SCREWS WERE NOT RECOVERABLE. DUE TO THE 2 SCREW HEADS BREAKING OFF, THE SURGEON DECIDED TO REMOVE THE PLATE ALONG WITH THE OTHER SCREWS THAT WERE FULLY INTACT AND USE A TENSION BAND INSTEAD. THERE WAS A SURGICAL DELAY OF 20 MINUTES DUE TO THE REMOVAL OF THE PLATE AND SCREWS AND USING A DIFFERENT TECHNIQUE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991842 ↗
• InjuryApr 3, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS USING A VARIABLE ANGLE (VA) HANDSET TO PUT IN LAG SCREWS AND ONE 1.3 CORTEX SCREW. WHILE THE SURGEON WAS INSERTING THE SCREW, THE 1.3 CORTEX SCREW BROKE AT THE HEAD. THE SURGEON LEFT THE BROKEN PORTION OF THE SCREW IN THE PATIENT AND ADDED ANOTHER SCREW TO ENSURE STABILITY. THERE WAS A LESS THAN 5 MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES 1 1.3MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9922635 ↗
• MalfunctionJul 8, 2019Device Handling Problem; Device Handling Problem

  CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1).

  Patient problems: No Patient Involvement

  MAUDE report 8769814 ↗
• MalfunctionJul 8, 2019Device Handling Problem; Device Handling Problem

  CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1).

  Patient problems: No Patient Involvement

  MAUDE report 8769813 ↗
• MalfunctionJul 8, 2019Device Handling Problem; Device Handling Problem

  CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1).

  Patient problems: No Patient Involvement

  MAUDE report 8769812 ↗