NA 02.214.111Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982055453), received between Aug 28, 2019 and Sep 19, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 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 23101345 ↗
• 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 23101339 ↗
• 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 23101321 ↗
• MalfunctionFeb 19, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE 11MM SCREW IN QUESTION WAS USED WHILE ADJUSTING THE PLATE. HOWEVER THE RECESS OF THE PLATE WAS COMPROMISED BY THE SCREWDRIVER, PREVENTING IT FROM BEING INSERTED PROPERLY INTO THE PLATE. A 12MM SCREW WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 11MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18732495 ↗
• MalfunctionNov 18, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828120 ↗
• MalfunctionApr 26, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HAND SURGERY PROCEDURE. INITIAL INJURY WAS SUSTAINED FROM A GUNSHOT WOUND TO THE HAND. WHILE INSERTING 1.5MM X 11MM CORTEX SCREWS DURING AN ORIF OF A METACARPAL, THE SURGEON HAD 4 SCREWS BRAKE/STRIP. ONE SCREW WAS REMOVED. ONE WAS IMPLANTED, BUT THE HEAD IS STRIPPED. TWO SCREWS HAD THEIR HEAD BREAK OFF WHILE BEING IMPLANTED. THE SURGEON WAS UNABLE TO REMOVE THE SHAFT OF THE 2 BROKEN SCREWS, THEY REMAINED IMPLANTED. IT WAS MENTIONED THE T4 SCREWDRIVER SHAFT WAS NOT HOLDING THE SCREWS VERY WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 11. THIS REPORT IS 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728673 ↗
• MalfunctionApr 26, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HAND SURGERY PROCEDURE. INITIAL INJURY WAS SUSTAINED FROM A GUNSHOT WOUND TO THE HAND. WHILE INSERTING 1.5MM X 11MM CORTEX SCREWS DURING AN ORIF OF A METACARPAL, THE SURGEON HAD 4 SCREWS BRAKE/STRIP. ONE SCREW WAS REMOVED. ONE WAS IMPLANTED, BUT THE HEAD IS STRIPPED. TWO SCREWS HAD THEIR HEAD BREAK OFF WHILE BEING IMPLANTED. THE SURGEON WAS UNABLE TO REMOVE THE SHAFT OF THE 2 BROKEN SCREWS, THEY REMAINED IMPLANTED. IT WAS MENTIONED THE T4 SCREWDRIVER SHAFT WAS NOT HOLDING THE SCREWS VERY WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 11. THIS REPORT IS 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728622 ↗
• InjuryAug 28, 2019Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, WHILE THE SURGEON WAS PUTTING A CORTEX SCREW SELF-TAPING INTO THE PLATE, THE HEAD OF CORTEX SCREW SNAPPED OFF. THE SURGEON SWITCHED TO A STRONGER PLATE AND SCREW 2.0MM CONSTRUCT AND COMPLETED THE CASE. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE. THE SURGEON TRIED EXTRACTING THE SHAFT OF SCREW BUT OPTED TO LEAVE IT IN BECAUSE IT WAS SO TINY; THE SURGEON WAS UNABLE TO GRIP IT TO GET IT OUT. THE SURGEON THEN ORIENTED THE LARGER PLATE OVER THE FRAGMENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF THREE TO FOUR (3-4) MINUTES. PATIENT OUTCOME IS UNKNOWN. NO REVISION SURGERY IS PLANNED. CONCOMITANT DEVICES: VARIABLE ANGLE LOCKING Y-PLATE (PART: 02.130.253, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 1.5MM CORTEX SCREW SELF-TAPPING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8941776 ↗