NA 02.214.112Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982055460), received between Jun 7, 2019 and Sep 19, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 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.

• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT FOUR (4) 1.5MM CORTEX SCREWS BROKE DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101355 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2021, DURING AN UNKNOWN PLATE IMPLANTATION, HEADS OF THE THERE (3) 1.5MM CORTEX SCREWS SNAPPED OFF DURING INSERTION. THE BROKEN SCREW HEADS WERE REMOVED. IN REMOVING THE SCREW SHAFTS, ONE OF THE SHAFTS BROKE A SECOND TIME. SURGEON HAD TO USE THE SCREW REMOVAL SET TO REMOVE THE BROKEN FRAGMENTS OF THE SCREWS. ALL FRAGMENTS WERE REMOVED SUCCESSFULLY WITH AN UNSPECIFIED AMOUNT OF A SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754555 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PLATE IMPLANTATION, HEADS OF THE THERE (3) 1.5MM CORTEX SCREWS SNAPPED OFF DURING INSERTION. THE BROKEN SCREW HEADS WERE REMOVED. IN REMOVING THE SCREW SHAFTS, ONE OF THE SHAFTS BROKE A SECOND TIME. SURGEON HAD TO USE THE SCREW REMOVAL SET TO REMOVE THE BROKEN FRAGMENTS OF THE SCREWS. ALL FRAGMENTS WERE REMOVED SUCCESSFULLY WITH AN UNSPECIFIED AMOUNT OF A SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754493 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PLATE IMPLANTATION, HEADS OF THE THERE (3) 1.5MM CORTEX SCREWS SNAPPED OFF DURING INSERTION. THE BROKEN SCREW HEADS WERE REMOVED. IN REMOVING THE SCREW SHAFTS, ONE OF THE SHAFTS BROKE A SECOND TIME. SURGEON HAD TO USE THE SCREW REMOVAL SET TO REMOVE THE BROKEN FRAGMENTS OF THE SCREWS. ALL FRAGMENTS WERE REMOVED SUCCESSFULLY WITH AN UNSPECIFIED AMOUNT OF A SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754484 ↗
• MalfunctionApr 27, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING PROCEDURE THE SCREW DRIVER SHAFT WAS NOT HOLDING A SCREW AND IS STRIPPING THE SCREWS. THE SCREW THAT WAS STRIPPED WAS NOT ABLE TO BE REMOVED FROM THE PATIENT, PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734878 ↗
• InjuryJun 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE METACARPALS. WHILE COVERING A CASE, ONE (1) 1.5 MM/16 MM CORTEX SCREW SELF TAPPING AND ONE (1) 1.5 MM/12 MM CORTEX SCREW SELF TAPPING BROKE WHILE INSERTING AND AS WELL AS ONE (1) DRILL BIT BROKE. SCREW HEADS SNAPPED OFF AND SURGEON BURRED THE SCREW DOWN SO IT WAS FLUSH. A DRILL BIT ALSO BROKE. THERE WERE FRAGMENTS GENERATED FROM BROKEN DEVICE BUT WAS NOT EASILY REMOVED. THE SURGEON ATTEMPTED TO REMOVE THE SCREW WITH SOME PLIERS AND COULD NOT GET IT OUT AND CHOSE TO BURR THE PROUD PORTION OF THE SCREW SO THE FRAGMENT WAS FLUSH WITH BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 15 - 20 MINUTES SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.5 MM CORTEX SCREW SELF TAPPING 12 MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8680035 ↗