NA 02.130.208Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982044624), received between Apr 11, 2018 and Apr 17, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THE DEVICE WAS NOT ENGAGING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16756255 ↗
• MalfunctionMar 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN HAND PROCEDURE, THE STARDRIVE SCREWS WERE DISCOVERED AS DAMAGED. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. THIS REPORT INVOLVES ONE (1) SCREW. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792146 ↗
• MalfunctionJan 14, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, DURING AN UNKNOWN HAND PROCEDURE, THE STARDRIVE SCREWS WERE DISCOVERED AS DAMAGED. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257904 ↗
• InjuryApr 11, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT TWO (2) LOCKING SCREWS WOULD NOT LOCK INTO AN UNKNOWN PLATE DURING A HAND FRACTURE REPAIR PROCEDURE ON (B)(6) 2018. THE SURGEON WAS MANUALLY PLACING SCREWS THROUGH THE SCREW HOLE OF THE PLATE WHEN THE TWO SCREWS MALFUNCTIONED. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT USING TWO CORTEX SCREWS. NO PATIENT HARM WAS REPORTED. THERE WAS A 45 SECOND SURGICAL DELAY RELATED TO SWITCHING THE SCREWS. THE PATIENT OUTCOME WAS REPORTED STABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7421354 ↗
• InjuryApr 11, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT TWO (2) LOCKING SCREWS WOULD NOT LOCK INTO AN UNKNOWN PLATE DURING A HAND FRACTURE REPAIR PROCEDURE ON (B)(6) 2018. THE SURGEON WAS MANUALLY PLACING SCREWS THROUGH THE SCREW HOLE OF THE PLATE WHEN THE TWO SCREWS MALFUNCTIONED. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT USING TWO CORTEX SCREWS. NO PATIENT HARM WAS REPORTED. THERE WAS A 45 SECOND SURGICAL DELAY RELATED TO SWITCHING THE SCREWS. THE PATIENT OUTCOME WAS REPORTED STABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7421352 ↗