NA 02.210.112TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982262660), received between Jul 30, 2020 and May 26, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL/REVISION SURGERY OF THE DISTAL RADIUS FOR UNKNOWN REASON AS PART OF 2 STAGE PLANNED PROCEDURE. REMOVAL OF CEMENT BLOCK FROM RADIAL SHAFT SECTION. TRANSPORT FIBULA TO RADIUS. FIX DISTAL RADIUS TO FIBULA TO ULNA WITH LONGER PLATE. THIS REPORT IS FOR (1) 2.4 VA LOCKING SCREW SD 12 STERILE. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14517055 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL/REVISION SURGERY OF THE DISTAL RADIUS FOR UNKNOWN REASON AS PART OF 2 STAGE PLANNED PROCEDURE. REMOVAL OF CEMENT BLOCK FROM RADIAL SHAFT SECTION. TRANSPORT FIBULA TO RADIUS. FIX DISTAL RADIUS TO FIBULA TO ULNA WITH LONGER PLATE. THIS REPORT IS FOR (1) 2.4 VA LOCKING SCREW SD 12 STERILE. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14516908 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL/REVISION SURGERY OF THE DISTAL RADIUS FOR UNKNOWN REASON AS PART OF 2 STAGE PLANNED PROCEDURE. REMOVAL OF CEMENT BLOCK FROM RADIAL SHAFT SECTION. TRANSPORT FIBULA TO RADIUS. FIX DISTAL RADIUS TO FIBULA TO ULNA WITH LONGER PLATE. THIS REPORT IS FOR (1) 2.4 VA LOCKING SCREW SD 12 STERILE. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14516894 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL/REVISION SURGERY OF THE DISTAL RADIUS FOR UNKNOWN REASON AS PART OF 2 STAGE PLANNED PROCEDURE. REMOVAL OF CEMENT BLOCK FROM RADIAL SHAFT SECTION. TRANSPORT FIBULA TO RADIUS. FIX DISTAL RADIUS TO FIBULA TO ULNA WITH LONGER PLATE. THIS REPORT IS FOR ONE (1) 2.4 VA LOCKING SCREW SD 12 STERILE. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14516826 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL/REVISION SURGERY OF THE DISTAL RADIUS FOR UNKNOWN REASON AS PART OF 2 STAGE PLANNED PROCEDURE. REMOVAL OF CEMENT BLOCK FROM RADIAL SHAFT SECTION. TRANSPORT FIBULA TO RADIUS. FIX DISTAL RADIUS TO FIBULA TO ULNA WITH LONGER PLATE. THIS REPORT IS FOR ONE 2.4 VA LOCKING SCREW SD 12 STERILE. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14516649 ↗
• MalfunctionJul 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SCREW WOULD NOT DISENGAGED FROM THE TUBE. IT IS UNKNOWN WHEN THE EVENT OCCURRED AND IF THERE WAS PATIENT OR PROCEDURAL INVOLVEMENT. THIS IS REPORT 2 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10343839 ↗
• MalfunctionJul 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SCREW WOULD NOT DISENGAGED FROM THE TUBE. IT IS UNKNOWN WHEN THE EVENT OCCURRED AND IF THERE WAS PATIENT OR PROCEDURAL INVOLVEMENT. THIS IS REPORT 1 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10343786 ↗

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-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-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-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