NA 04.210.118TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982262615), received between May 1, 2023 and Mar 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K071184, K100776, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE PROCEDURE, THE MOST DISTAL HOLE OF THE 2-HOLE PLATE MALFUNCTIONED AND COULD NOT BE LOCKED. THE 2-HOLE PLATE WAS REPLACED WITH A 3-HOLE PLATE, AND A DRILL GUIDE WAS USED WITHOUT A GUIDING BLOCK. THE VA-HOLE AREA SEEMED TO BE CRUSHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT, THEIR STATUS IS STABLE. NO FRAGMENTS WERE GENERATED, IT WAS CONFIRMED VIA X-RAY THAT NO PIECES WERE PRESENT IN THE PATIENT¿S BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939724 ↗
• MalfunctionMay 1, 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 USING VA-TCP FOR DISTAL RADIUS. DURING THE PROCEDURE, THE VA LOCKING SCREW IN QUESTION DID NOT PROPERLY MATCH WITH THE DRIVER. ALTHOUGH IT WAS INSERTED ONCE, THE SCREW WAS REMOVED WITHOUT BEING FULLY IMPLANTED IN CONSIDERATION OF REMOVAL IN THE FUTURE. OTHER SCREWS WORKED WITH NO ISSUES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845894 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071184, K100776, K102694, K103243. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-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-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and
• 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