NA 02.210.088Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982052728), received between Feb 26, 2019 and Jun 6, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 11 OF 11 FOR (B)(4). THIS REPORT IS FOR A BUTTRESS PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602033 ↗
• 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 10 OF 11 FOR (B)(4). THIS REPORT IS FOR A BUTTRESS PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601930 ↗
• 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 9 OF 11 FOR (B)(4). THIS REPORT IS FOR A BUTTRESS PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601787 ↗
• 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 4 OF 11 FOR (B)(4). THIS REPORT IS FOR A BUTTRESS PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601219 ↗
• 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 8371387 ↗

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