NA 02.210.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982052933), received between Jan 19, 2018 and Mar 19, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADS ON EITHER THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO COLUMN VOLAR DISTAL RADIUS PLATE OR THE FOUR (4) VARIABLE ANGLE (VA) LOCKING SCREWS STARDRIVE WERE STRIPPED PRIOR TO THE CASE. EACH SCREW INSERTED INTO THE TWO RADIAL STYLOID HOLES WOULD SPIN AND NOT LOCK IN. SURGEON HAD TO REMOVE THE PLATE ALL TOGETHER AND START OVER. ANOTHER SET WAS OPENED TO GET A NEW PLATE. THE SURGERY WAS DELAYED FOR THIRTY (30) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 16MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530682 ↗
• MalfunctionMar 19, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADS ON EITHER THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO COLUMN VOLAR DISTAL RADIUS PLATE OR THE FOUR (4) VARIABLE ANGLE (VA) LOCKING SCREWS STARDRIVE WERE STRIPPED PRIOR TO THE CASE. EACH SCREW INSERTED INTO THE TWO RADIAL STYLOID HOLES WOULD SPIN AND NOT LOCK IN. SURGEON HAD TO REMOVE THE PLATE ALL TOGETHER AND START OVER. ANOTHER SET WAS OPENED TO GET A NEW PLATE. THE SURGERY WAS DELAYED FOR 30 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR 1 2.4MM VA LOCKING SCREW STARDRIVE 16MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530672 ↗
• MalfunctionMar 19, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADS ON EITHER THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO COLUMN VOLAR DISTAL RADIUS PLATE OR THE FOUR (4) VARIABLE ANGLE (VA) LOCKING SCREWS STARDRIVE WERE STRIPPED PRIOR TO THE CASE. EACH SCREW INSERTED INTO THE TWO RADIAL STYLOID HOLES WOULD SPIN AND NOT LOCK IN. SURGEON HAD TO REMOVE THE PLATE ALL TOGETHER AND START OVER. ANOTHER SET WAS OPENED TO GET A NEW PLATE. THE SURGERY WAS DELAYED FOR THIRTY (30) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 16MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530656 ↗
• MalfunctionMar 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN (B)(6) 2021 THE 2.4MM VARIABLE LOCKING COMPRESSION PLATE WAS NOT ABLE TO LOCK INTO A SCREW IN THE LEFT-MOST DISTAL ULNAR COLUMN SCREW. A TOTAL OF THREE (3) LOCKING SCREWS AND ONE (1) PLATE WERE TRIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 16MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497399 ↗
• MalfunctionMar 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN (B)(6), 2021 THE 2.4MM VARIABLE LOCKING COMPRESSION PLATE WAS NOT ABLE TO LOCK INTO A SCREW IN THE LEFT-MOST DISTAL ULNAR COLUMN SCREW. A TOTAL OF THREE (3) LOCKING SCREWS AND ONE (1) PLATE WERE TRIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 16MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497368 ↗
• MalfunctionMar 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN (B)(6) 2021 THE 2.4MM VARIABLE LOCKING COMPRESSION PLATE WAS NOT ABLE TO LOCK INTO A SCREW IN THE LEFT-MOST DISTAL ULNAR COLUMN SCREW. A TOTAL OF THREE (3) LOCKING SCREWS AND ONE (1) PLATE WERE TRIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 16MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497348 ↗
• MalfunctionMay 24, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON RECEIVING DELIVERY ON AN UNKNOWN DATE, TWO (2) DRILL BIT WITH DEPTH MARK QUICK COUPLING AND SIX (6) VARIABLE ANGLE LOCKING SCREW WITH STARDRIVE RECESS PACKAGE ARRIVED EMPTY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 2.4MM VA LOCKING SCREW STARDRIVE 16MM. THIS IS REPORT 4 OF 8 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8641978 ↗
• MalfunctionFeb 13, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT ON (B)(6) 2019, THERE WAS A MISSING DEVICE FROM THE PACKAGE. IT WAS NOTICED WHEN THEY WENT TO FILLED UP THE TRAY AND WHEN THEY OPENED UP FOR THE SCREW IT WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8335849 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, WHO WAS IMPLANTED WITH A SYNTHES DISTAL RADIUS PLATE AND SCREWS ON (B)(6) 2017, EXPERIENCED AN INFECTION AT THE IMPLANT SITE. THE PATIENT WAS REVISED ON (B)(6) 2017, WHEN THE PLATE WAS LEFT IMPLANTED AND FOUR 2.4 MM VARIABLE ANGLE LOCKING SCREWS WERE EXPLANTED. FOUR OF THE SCREWS WERE REPLACED WITH THREE NEW SCREWS (12 MM, 16 MM AND 20 MM LENGTHS X 1 EACH). THE PATIENT'S WOUND WAS CLEANED OUT AND THE SURGEON RE-POSITIONED AND REPLACED THE SCREWS TO GET THE BETTER PURCHASE OF THE PATIENT BONE. ONE OF THE SCREWS WAS NOT REPLACED. THE SURGEON FELT THAT MAKING THE CONSTRUCT MORE STABLE WOULD BE MORE BENEFICIAL FOR THE PATIENT THAN JUST CLEANING THE WOUND ALONE. THERE WERE NO REPORTS THAT THE DEVICE HAD LOOSENED, MIGRATED, BACKED-OUT OR MALFUNCTIONED. THE PATIENT WAS REPORTED TO BE ON STEROIDS AND BE SUBSEQUENTLY IMMUNOCOMPROMISED. THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE. IT IS UNKNOWN IF THE INFECTION HAS SUBSIDED. THIS REPORT IS FOR ONE (1) 2.4 MM VA LOCKING SCREW STARDRIVE 16 MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7205660 ↗

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-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-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-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-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