NA 02.214.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982055446), received between Jan 18, 2019 and Mar 20, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE SECOND METACARPAL, THE SCREW HEAD CUT OFF WHILE THE SURGEON INSERTED THE CORTEX SCREW INTO A PLATE. THE SURGEON HAD TO THEN REMOVE THE PLATE. THERE WAS DIFFICULTY REMOVING THE OTHER HALF OF THE SCREW IN THE BONE. IT WAS REMOVED USING A BROKEN SCREW REMOVAL SET. THE SURGEON THEN PLACED THE PLATE BACK ON AND FINISHED THE PROCEDURE WITH NEW SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIFTEEN (15) MINUTE SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8437374 ↗
• MalfunctionJan 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) CORTEX SCREWS DID NOT HOLD ONTO THE UNKNOWN SCREWDRIVER. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED. CONCOMITANT MEDICAL PRODUCT: UNKNOWN - SCREWDRIVER: (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8287020 ↗
• MalfunctionJan 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) CORTEX SCREWS DID NOT HOLD ONTO THE UNKNOWN SCREWDRIVER. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED. CONCOMITANT DEVICES REPORTED: UNKNOWN - SCREWDRIVER: (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8282811 ↗
• MalfunctionJan 18, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2018, THE TIP OF THE STARDRIVE SCREWDRIVER SHAFT HAD TWISTED AND DID NOT FIT PROPERLY INTO THE HEAD OF THE CORTEX. WHILE THE SURGEON WAS PUTTING THE SCREW THROUGH THE PLATE, THE HEAD OF THE SCREW WAS STRIPPED BUT WAS INSERTED SUCCESSFULLY INTO THE PLATE. THE PLATE HAD NO MALFUNCTION. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES DUE TO AN ATTEMPT TO REMOVE THE SCREW. IT WAS NOTED THAT THE STRIPPED SCREW STILL PROVIDED ADEQUATE FIXATION FOR THIS PROCEDURE BUT MAY BE DIFFICULT TO REMOVE IN THE EVENT THAT THE HARDWARE SHOULD EVER NEED TO BE REMOVED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVED TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 8261909 ↗