NA 412.824Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982211668), received between Apr 24, 2018 and Apr 24, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2018 AFTER THE PATIENT PRESENTED PAIN IN THE WRIST FOLLOWING AN UNKNOWN PROCEDURE. X-RAYS WERE TAKEN AND REVEALED BROKEN SCREWS AND LOSS OF REDUCTION. THE SURGEON REMOVED THE FOUR BROKEN SCREWS, AN UNKNOWN QUANTITY OF LOCKING SCREWS (NOT BROKEN) AND THE 2.4 VA-LCP TWO COLUMN PLATE AND REPLACED THEM WITH A COMPETITOR¿S PRODUCT (HAND INNOVATIONS). NO FRAGMENTS WERE GENERATED FROM THE BROKEN SCREWS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAYS AND NO HARM TO THE PATIENT. CONCOMITANT DEVICES REPORTED: 2.4MM TI VA-LCP 2-CLMN VLR (PART 04.111.631, LOT UNKNOWN, QTY 1), UNKNOWN LOCKING SCREWS (PART UNKNOWN, LOT UNKNOWN, QTY UNKNOWN). THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7455829 ↗

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-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-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-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