NA 02.210.118Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982052957), received between Jan 19, 2018 and Feb 18, 2026 — classified as 8 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (7 reports).

9 other recalls cover devices cleared under the same FDA submission (K071184, 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT CUSTOMER REPORTED RECEIVED THE CORRECT PACKAGE, HOWEVER THE ITEM INSIDE WAS INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378132 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS REMOVING 2.4MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE BECAUSE THE PATIENT HAD TENDON IRRITATION. EVERYTHING WAS REMOVED SUCCESSFULLY. THERE IS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.4MM VA LOCKING SCREW STARDRIVE 20 MM. THIS REPORT IS 8 OF 10 (B)(4).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11842174 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS REMOVING 2.4MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE BECAUSE THE PATIENT HAD TENDON IRRITATION. EVERYTHING WAS REMOVED SUCCESSFULLY. THERE IS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.4MM VA LOCKING SCREW STARDRIVE 18MM. THIS REPORT IS 6 OF 10 (B)(4).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11842170 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APRIL 21, 2021, THE SURGEON WAS REMOVING 2.4MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE BECAUSE THE PATIENT HAD TENDON IRRITATION. EVERYTHING WAS REMOVED SUCCESSFULLY. THERE IS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.4MM VA LOCKING SCREW STARDRIVE 20 MM. THIS REPORT IS 7 OF 10 (B)(4).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11842168 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS REMOVING 2.4MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE BECAUSE THE PATIENT HAD TENDON IRRITATION. EVERYTHING WAS REMOVED SUCCESSFULLY. THERE IS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.4MM VA LOCKING SCREW STARDRIVE 18MM THIS REPORT IS 4 OF 10 (B)(4).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11842154 ↗
• 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 18MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530670 ↗
• MalfunctionJan 29, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.4MM VA LOCKING SCREW STARDRIVE PACKAGE WAS ORDERED BUT THE PACKAGE THAT WAS DELIVERED WAS EMPTY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 18MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11253207 ↗
• MalfunctionJan 20, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE TWO (2) 2.4MM VA LOCKING SCREW STARDRIVE PACKAGES WERE UNSEALED ALONG THE EDGE AND THERE WERE NO PRODUCTS IN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 18MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202431 ↗
• MalfunctionJan 20, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE TWO (2) 2.4MM VA LOCKING SCREW STARDRIVE PACKAGES WERE UNSEALED ALONG THE EDGE AND THERE WERE NO PRODUCTS IN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STARDRIVE 18MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202411 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A CONTACT DERMATITIS DUE TO AN ALLERGIC REACTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS SYSTEM ON AN UNKNOWN DATE. THE PATIENT IS NOW TAKING STEROIDS FOR CONTACT DERMATITIS AND DOES NOT REQUIRE REVISION SURGERY. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS IS 3 OF 5 FOR REPORT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9856821 ↗
• 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 NINE (9) 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 18MM. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8642284 ↗
• 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 18MM. THIS IS REPORT 8 OF 8 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8642123 ↗
• 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 18MM. THIS IS REPORT 5 OF 8 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8642025 ↗
• MalfunctionFeb 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: 1.8MM DRILL BIT (PART # 310.509, LOT UNKNOWN, QUANTITY 1), VARIABLE ANGLE GUIDE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371384 ↗
• MalfunctionFeb 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: 1.8MM DRILL BIT (PART # 310.509 , LOT UNKNOWN, QUANTITY 1), VARIABLE ANGLE GUIDE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371378 ↗
• MalfunctionFeb 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: 1.8MM DRILL BIT (PART # 310.509 , LOT UNKNOWN, QUANTITY 1), VARIABLE ANGLE GUIDE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371375 ↗
• InjuryJul 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE VARIABLE ANGLE LOCKING SCREW DID NOT LOCK INTO THE VOLAR DISTAL RADIUS PLATE. BOTH DEVICES ARE CURRENTLY IMPLANTED IN THE PATIENT. IT WAS UNKNOWN WHERE THE ISSUE WAS OBSERVED. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7681245 ↗
• 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 2.4MM VARIABLE ANGLE LOCKING SCREWS WERE EXPLANTED. FOUR OF THE SCREWS WERE REPLACED WITH THREE NEW SCREWS (12MM, 16MM AND 20MM LENGTHS X1 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) 2.4MM VA LOCKING SCREW STARDRIVE 18MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7205656 ↗
• 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 X1 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 18 MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7205655 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071184, 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-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-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-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