NA 02.210.124Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982053015), received between Dec 5, 2017 and Jun 24, 2022 — classified as 3 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K071184, K100776, K102694); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2022Break

  DURING OR PROCEDURE TO REMOVE HARDWARE FROM RIGHT WRIST, THE HEAD OF A SCREW BROKE OFF WHILE THE SURGEON WAS REMOVING THE SCREW. THE SURGEON WAS ABLE TO REMOVE ALL PARTS AND NO PARTS WERE RETAINED. THIS WAS CONFIRMED BY X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799091 ↗
• MalfunctionMar 20, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FACILITY PURCHASED 2.4MM VARIABLE LOCKING SCREW STARDRIVE; HOWEVER, THE FACILITY RECEIVED AN EMPTY SEALED PACKAGE, WITH NO SCREW IN IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES 2.4MM VA LOCKING SCREW STARDRIVE 24MM (QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9861220 ↗
• MalfunctionDec 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE OF (B)(6) 2017, A VARIABLE ANGLE (VA) LOCKING SCREW WAS OUT IN ON POWER WITH A TORQUE LIMITER AND WENT ALL THE WAY THROUGH THE PLATE. SCREW WAS EASILY RETRIEVED WITHIN 2-3 MINUTES AND WAS SUCCESSFULLY REPLACED WITH A DIFFERENT SCREW. THE SURGERY WENT AS PLANNED. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW STAR DRIVE 24MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7084661 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071184, K100776, K102694. One submission often covers many models, so check the product and lot details in each record.

• 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