NA 03.130.201Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982075321), received between Oct 29, 2018 and Mar 29, 2022 — classified as 2 injuries, 2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE SURGEON TWISTED THE TOP OFF A 9MM TI CORTEX SCREW (1.5MM SET) AND BROKE A 1.1MM DRILL BIT; BOTH BROKE INSIDE THE PATIENT AND ALL PIECES WERE REMOVED. X-RAYS WERE TAKEN TO AID THE REMOVAL PROCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FORTY-FIVE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 1.1MM DRILL BIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938997 ↗
• InjuryAug 26, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE, SURGEON WAS PLATING THE THIRD MC HAND FRACTURE AND BROKE THE HEADS OFF OF THREE (3) 1.5MM VARIABLE ANGLE LOCKING SCREWS, AND ONE (1) 1.5MM CORTEX SCREW. THE HEADS WERE RETRIEVED BUT THE SCREW SHAFTS REMAINED IN THE PATIENT. THE SURGEON ALSO BROKE THE TIP OFF TWO (2) 1.1MM DRILL BITS. ONE (1) WAS RETRIEVED AND A 4MM LENGTH PIECE OF THE OTHER WAS LEFT IN THE PATIENT. THE SURGEON DETERMINED A STABLE FIXATION WITH THE SCREWS THAT WERE NOT BROKEN. A CIRCLAGE WIRE WAS PLACED AROUND THE PLATE BOTH PROXIMALLY AND DISTALLY. FRAGMENTS GENERATED FROM THE BROKEN SCREW SHAFTS AND A 4MM SEGMENT OF THE DRILL BIT WERE LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 1.5MM VA-LCK SCR SLF-TP W T4 STARDRIVE13MM, 1.5MM VA-LCK SCR SLF-TP W T4 STARDRIVE12MM, 1.5MM VA-LCK SCR SLF-TP W T4 STARDRIVE11MM, 1.5MM CRTX SCRW SLF-TP W T4 STARDR REC 11MM, 1.1MM DR BIT/STRYK J-LATCH F HL/65MM. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/STRYKER J-LATCH F/THREADED HOLE/65MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10456811 ↗
• MalfunctionAug 26, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE, SURGEON WAS PLATING THE THIRD MC HAND FRACTURE AND BROKE THE HEADS OFF OF THREE (3) 1.5MM VARIABLE ANGLE LOCKING SCREWS, AND ONE (1) 1.5MM CORTEX SCREW. THE HEADS WERE RETRIEVED BUT THE SCREW SHAFTS REMAINED IN THE PATIENT. THE SURGEON ALSO BROKE THE TIP OFF TWO (2) 1.1MM DRILL BITS. ONE (1) WAS RETRIEVED AND A 4MM LENGTH PIECE OF THE OTHER WAS LEFT IN THE PATIENT. THE SURGEON DETERMINED A STABLE FIXATION WITH THE SCREWS THAT WERE NOT BROKEN. A CIRCLAGE WIRE WAS PLACED AROUND THE PLATE BOTH PROXIMALLY AND DISTALLY. FRAGMENTS GENERATED FROM THE BROKEN SCREW SHAFTS AND A 4MM SEGMENT OF THE DRILL BIT WERE LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 1.5MM VA-LCK SCR SLF-TP W T4 STARDRIVE13MM, 1.5MM VA-LCK SCR SLF-TP W T4 STARDRIVE12MM, 1.5MM VA-LCK SCR SLF-TP W T4 STARDRIVE11MM, 1.5MM CRTX SCRW SLF-TP W T4 STARDR REC 11MM, 1.1MM DR BIT/STRYK J-LATCH F HL/65MM. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/STRYKER J-LATCH F/THREADED HOLE/65MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10456810 ↗
• InjuryOct 29, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE DRILL BIT BROKE DURING A HAND SURGERY AND THE PIECE WAS LEFT INSIDE OF THE PATIENT. ALSO, THE STARDRIVE SCREWDRIVER SHAFTS BECAME TWISTED DURING IMPLANTATION OF UNKNOWN SCREWS CAUSING THE SCREWS TO STRIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY FURTHER ISSUES. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/STRYKER J-LATCH F/THREADED HOLE/65MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8016809 ↗