NA 04.214.111Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982120861), received between Jul 13, 2018 and Jul 3, 2019 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF METACARPAL, THE SURGEON MOLDED THE 1.5MM TITANIUM PLATE TO FIT THE ANATOMY, THEN PROCEEDED TO DRILL BICORTICAL USING A 1.1MM DRILL BIT. THEN, MEASURED AND PROCEEDED TO INSERT A 1.5X11MM CORTICAL SCREW. DURING INSERTION, THE HEAD OF THE SCREW SEPARATED AND TWISTED OFF, LEAVING THE REMAINING PORTION OF THE SCREW IN THE BONE. DRILLED A DIFFERENT HOLE IN THE SAME PLATE USING THE SAME DRILL BIT. PUT ANOTHER ONE (1) CORTEX SCREW, AND THE SAME EVENT HAPPENED WITH THE SECOND SCREW AS THE FIRST. BOTH REMAINING PORTIONS OF THE SCREWS WERE LEFT IN THE PATIENT AND THE PORTION OF THE SCREWS THAT WERE BROKEN WERE SAVED AND SENT BACK TO THE COMPANY. THE SURGEON RESORTED TO A 2MM PLATE AND 2MM SCREWS TO FINISH THE CASE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPETED. PATIENT OUTCOME WAS SATISFACTORY. CONCOMITANT DEVICE REPORTED: 1.1MM DRILL BIT (PART # 03.130.200, LOT # F-26584, QUANTITY # 1), TITANIUM VARIABLE ANGLE LOCKING T-PLATE (PART # 04.130.252, LOT # L866052, QUANTITY # 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8757504 ↗
• InjuryJul 3, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF METACARPAL, THE SURGEON MOLDED THE 1.5MM TITANIUM PLATE TO FIT THE ANATOMY, THEN PROCEEDED TO DRILL BICORTICAL USING A 1.1MM DRILL BIT. THEN, MEASURED AND PROCEEDED TO INSERT A 1.5X11MM CORTICAL SCREW. DURING INSERTION, THE HEAD OF THE SCREW SEPARATED AND TWISTED OFF, LEAVING THE REMAINING PORTION OF THE SCREW IN THE BONE. DRILLED A DIFFERENT HOLE IN THE SAME PLATE USING THE SAME DRILL BIT. PUT ANOTHER ONE (1) CORTEX SCREW, AND THE SAME EVENT HAPPENED WITH THE SECOND SCREW AS THE FIRST. BOTH REMAINING PORTIONS OF THE SCREWS WERE LEFT IN THE PATIENT AND THE PORTION OF THE SCREWS THAT WERE BROKEN WERE SAVED AND SENT BACK TO THE COMPANY. THE SURGEON RESORTED TO A 2MM PLATE AND 2MM SCREWS TO FINISH THE CASE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPETED. PATIENT OUTCOME WAS SATISFACTORY. CONCOMITANT DEVICE REPORTED: 1.1MM DRILL BIT (PART # 03.130.200, LOT # F-26584, QUANTITY # 1); TITANIUM VARIABLE ANGLE LOCKING T-PLATE (PART # 04.130.252, LOT # L866052, QUANTITY # 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8757395 ↗
• MalfunctionAug 15, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HAND SURGERY ON (B)(6) 2018. DURING INSERTION, TWO (2) TITANIUM CORTEX SCREWS BROKE. THE SURGEON CHOSE TO LEAVE THE TWO (2) BROKEN SCREW SHAFTS IN PLACE AND MORE SCREWS WERE THEN INSERTED. IT WAS NOTED THE SURGEON HAD DIFFICULTY INSERTING ONE OF THE SCREWS THAT WAS THE SAME SIZE AS THE TWO THAT BROKE. THE BONE WAS PREDRILLED AND REPORTEDLY THE DRILL BIT ALSO BROKE. NO EXTRA SURGICAL ACTIONS WERE REQUIRED. THERE WERE NO FRAGMENTS GENERATED FROM BROKEN DEVICES. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. WHEN THE DEVICE WAS BEING INVESTIGATED BY THE MANUFACTURE, IT WAS NOTED THE RETURNED SCREW WAS STRIPPED AT ITS DISTAL THREAD REGIONS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784551 ↗
• MalfunctionJul 13, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HAND SURGERY ON (B)(6) 2018, WHEN THE SURGEON INSERTED THE TWO (2) TITANIUM CORTEX SCREWS, THEY BROKE; THE SURGEON CHOSE TO LEAVE THE TWO (2) BROKEN SCREW SHAFTS IN PLACE. MORE SCREWS WERE THEN INSERTED. NO ADDITIONAL SURGICAL ACTIONS REQUIRED. THERE WERE NO FRAGMENTS GENERATED FROM BROKEN DEVICE. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7686059 ↗
• MalfunctionJul 13, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HAND SURGERY ON (B)(6) 2018, WHEN THE SURGEON INSERTED THE TWO (2) TITANIUM CORTEX SCREWS, THEY BROKE; THE SURGEON CHOSE TO LEAVE THE TWO (2) BROKEN SCREW SHAFTS IN PLACE. MORE SCREWS WERE THEN INSERTED. NO ADDITIONAL SURGICAL ACTIONS REQUIRED. THERE WERE NO FRAGMENTS GENERATED FROM BROKEN DEVICE. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7685948 ↗