NA 04.210.114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982118509), received between Feb 25, 2020 and Aug 29, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionAug 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR FRACTURE OF THE DISTAL END OF THE RIGHT RADIUS WITH VA LOCKING SCREW. WHEN THE SURGEON INSERTED THE VA LOCKING SCREW IN QUESTION, THE LOCKING MECHANISM DID NOT FUNCTION PROPERLY BETWEEN THE THREADING OF THE PLATE HOLE AND THE SCREW HEAD. THE SURGEON REMOVED THE SCREW AND INSERTED ANOTHER OF THE SAME SIZE, THIS TIME THE LOCKING MECHANISM FUNCTIONED PROPERLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641734 ↗
• InjuryFeb 25, 2020Crack; Crack

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT COMPLAINED OF SPONTANEOUS PAIN AND DEFORMITY. RADIOGRAPHY SHOWED THAT THE PLATE WAS BROKEN. INITIALLY, PATIENT UNDERWENT RADIUS OSTEOTOMY FOR STRETCHING AND CORRECTION OF BILATERAL MADELUNG DEFORMITY, AND OSTEOTOMY WITH ULNA SHORTENING ON (B)(6) 2019. REVISION SURGERY AND HARDWARE REMOVAL OCCURRED (B)(6) 2019. CONCOMITANT DEVICES: UNKNOWN CORTICAL SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) AND UNKNOWN LOCKING SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 7) THIS REPORT IS FOR A 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9749983 ↗

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-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-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-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-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