NA 412.814Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982211613), received between Apr 10, 2023 and Jan 30, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).

11 other recalls cover devices cleared under the same FDA submission (K012114, K050110, K063049, K102694, K103243); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A DISTAL ULNA FRACTURE WITH THE DISTAL RADIUS PLATE AND LOCKING SCREWS ON (B)(6) 2024. AFTER THE SURGEON FIXED THE PLATE WITH THREE CORTEX SCREWS, HE INSERTED LOCKING SCREWS AT THE DISTAL AND PROXIMAL ENDS, BUT THE LOCKING SCREWS PENETRATED THE SCREW HOLES IN THE PLATE. THE SALES REPRESENTATIVE ALSO CONFIRMED THAT THE LOCKING SCREW PENETRATED THROUGH THE SCREW HOLE WITHOUT GETTING CAUGHT. THE SURGEON DETERMINED THAT FIXATION COULD NOT BE ACHIEVED IN THIS CONDITION, SO THE DISTAL RADIUS PLATE WAS REMOVED, AND THE WOUND WAS SWITCHED TO A FIXATION WITH A K-WIRE AND CLOSED. THE SURGERY WAS EXTENDED BY 30 MINUTES DUE TO THE EVENT, AND THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18608804 ↗
• MalfunctionJan 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A DISTAL ULNA FRACTURE WITH THE DISTAL RADIUS PLATE AND LOCKING SCREWS ON (B)(6) 2024. AFTER THE SURGEON FIXED THE PLATE WITH THREE CORTEX SCREWS, HE INSERTED LOCKING SCREWS AT THE DISTAL AND PROXIMAL ENDS, BUT THE LOCKING SCREWS PENETRATED THE SCREW HOLES IN THE PLATE. THE SALES REPRESENTATIVE ALSO CONFIRMED THAT THE LOCKING SCREW PENETRATED THROUGH THE SCREW HOLE WITHOUT GETTING CAUGHT. THE SURGEON DETERMINED THAT FIXATION COULD NOT BE ACHIEVED IN THIS CONDITION, SO THE DISTAL RADIUS PLATE WAS REMOVED, AND THE WOUND WAS SWITCHED TO A FIXATION WITH A K-WIRE AND CLOSED. THE SURGERY WAS EXTENDED BY 30 MINUTES DUE TO THE EVENT, AND THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM. THIS IS REPORT 1 OF 3 FOR, (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18608799 ↗
• MalfunctionJan 11, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 19, 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A DISTAL RADIUS FRACTURE. WHEN INSERTING THE TI LOCKING SCREW INTO THE DIAPHYSIS, IT WAS DIFFICULT TO ENGAGE WITH THE T8 SCREWDRIVER AND THE THREADS OF THE SCREW STRIPPED. THE SAME SIZE SCREW WAS USED, BUT SO WAS THAT ONE. THE SCREWDRIVER WAS CHANGED, BUT THE SITUATION REMAINED THE SAME. THE SURGEON INSERTED A VA LOCKING SCREW 2.4 14MM AND COMPLETED THE SURGERY WITH NO PROBLEMS WITHIN 30 MINUTES DELAY. THERE IS ALSO A POSSIBILITY THAT THE THREADS OF THE T8 SCREWDRIVER MAY STRIPPED. PATIENT STATUS/ OUTCOME: STABLE. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LOCKSCR ø2.4 SELF-TAP L14 TAN THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495347 ↗
• MalfunctionJan 11, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A DISTAL RADIUS FRACTURE. WHEN INSERTING THE TI LOCKING SCREW INTO THE DIAPHYSIS, IT WAS DIFFICULT TO ENGAGE WITH THE T8 SCREWDRIVER AND THE THREADS OF THE SCREW STRIPPED. THE SAME SIZE SCREW WAS USED, BUT SO WAS THAT ONE. THE SCREWDRIVER WAS CHANGED, BUT THE SITUATION REMAINED THE SAME. THE SURGEON INSERTED A VA LOCKING SCREW 2.4 14MM AND COMPLETED THE SURGERY WITH NO PROBLEMS WITHIN 30 MINUTES DELAY. THERE IS ALSO A POSSIBILITY THAT THE THREADS OF THE T8 SCREWDRIVER MAY STRIPPED. PATIENT STATUS/ OUTCOME: STABLE. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LOCKSCR ø2.4 SELF-TAP L14 TAN. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495289 ↗
• MalfunctionJul 21, 2023Difficult to Advance; Difficult to Advance

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION/INTERNAL FIXATION SURGERY ON (B)(6) 2023, THE SURGEON COULD NOT FEEL THE PLATE AND SCREW ENGAGE WHEN THE SCREW WAS INSERTED INTO THE NEAREST OUTER HOLE OF AN LCP RADIAL HEAD RIM PLATE USING A NON-TORQUE LIMITATION SCREWDRIVER. A TORQUE LIMITATION SCREWDRIVER WAS THEN USED, BUT THE SCREW COULD NOT BE TIGHTENED AND BECAME IDLED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON COMMENTED THAT THERE WAS NO PROBLEM WITH BONE FIXATION. THIS REPORT INVOLVES ONE 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372497 ↗
• MalfunctionApr 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY FOR RIGHT DISTAL RADIAL METAPHYSEAL FRACTURE WITH A VA TCP 5 HOLE PLATE. DURING THE PROCEDURE THE FOLLOWING EVENTS OCCURRED: - THE PLATE WAS TEMPORARILY FIXED DISTALLY ONTO THE BONE THAT WAS TEMPORARILY FIXED BY REDUCTION. - AFTER INSERTING A 2.7MM CORTEX SCREW INTO THE SHAFT, THE TI LOCKING SCREW WAS INSERTED INTO THE THIRD PROXIMAL HOLE. THE SCREW INSERTION WAS A LITTLE DIFFICULT. - A DIRECTION CORRECTION WAS REQUIRED, AND THE TI LOCKING SCREW HEAD STRIPPED WHEN IT WAS ATTEMPTED TO REMOVE. - A NEW SCREW OF THE SAME SIZE WAS USED, AND THE SCREWDRIVER SHAFT WAS REPLACED WITH A LONGER ONE. THIS ALLOWED THE FIXATION TO BE COMPLETED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709334 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012114, K050110, K063049, K102694, K103243. One submission often covers many models, so check the product and lot details in each record.

• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor
• Z-0489-2007 · Dec 5, 2006 · Terminated
  LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465