NA 02.210.090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982052735), received between Jun 6, 2022 and Oct 16, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K092556, 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 16, 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.

• MalfunctionOct 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT IN (B)(6) 2023, THE SURGEON WAS PUTTING IN A VA BUTTRESS SCREW INTO THE MOST RADIAL PROXIMAL PORTION OF THE DISTAL SCREWS FOR PLATE 02.111.730 AND THE THREADS FROM THE SCREW WOULD NOT LOCK INTO THE PLATE. THE SCREW WAS EXCHANGED FOR ANOTHER VA BUTTRESS SCREW AND THE THREADS OF THE SECOND SCREW WOULD NOT LOCK INTO THE PLATE EITHER. THE GUIDE BLOCK AND DRILL GUIDE FOR GUIDE BLOCK WERE USED PROPERLY. ALL OTHER SCREWS LOCKED INTO THE PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 15 MINUTES OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR AN UNK - SCREW: TRAUMA. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17939909 ↗
• MalfunctionJun 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN ORTHOPEDIC PROCEDURE, THE SCREWS WOULD NOT LOCK IN 2 VARIABLE ANGLE (VA) DISTAL RADIUS PLATES. MULTIPLE LOCKING BUTTRESS PINS AND LOCKING SCREWS WERE TRIED ON 2 DIFFERENT PLATES. THEY COULD NOT GET THE LOCKING SCREWS TO ENGAGE THE PLATE. A SCREW IN DRILL GUIDE WOULD LOCK IN CORRECTLY HOWEVER, EVENTUALLY A 6 HOLE LCP VOLAR COLUMN PLATE WAS USED THAT WORKED FINE. ADDITIONAL X-RAYS WERE TAKEN. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS IS REPORT 8 OF 11 FOR (B)(4). THIS REPORT IS FOR A BUTTRESS PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601647 ↗
• MalfunctionJun 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022. DURING AN ORTHOPEDIC PROCEDURE, THE SCREWS WOULD NOT LOCK IN 2 VARIABLE ANGLE (VA) DISTAL RADIUS PLATES. MULTIPLE LOCKING BUTTRESS PINS AND LOCKING SCREWS WERE TRIED ON 2 DIFFERENT PLATES. THEY COULD NOT GET THE LOCKING SCREWS TO ENGAGE THE PLATE. A SCREW IN DRILL GUIDE WOULD LOCK IN CORRECTLY HOWEVER, EVENTUALLY A 6 HOLE LCP VOLAR COLUMN PLATE WAS USED THAT WORKED FINE. ADDITIONAL X-RAYS WERE TAKEN. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 11 FOR (B)(4). THIS REPORT IS FOR A BUTTRESS PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601093 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092556, 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