NA 02.130.355Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982045416), received between Apr 19, 2022 and Sep 20, 2024 — classified as 2 injuries, 1 malfunction.

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

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.

• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE PLATE BROKE WHILE BENDING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268060 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HAND PLATES. IN COLLABORATION WITH DEPUY SYNTHES, TOGETHER WITH CLEVELAND CLINIC FOUNDATION (CCF) DATABASE DESIGNERS, PROGRAM MANAGERS, RESEARCH ASSISTANTS, AND BIOSTATISTICIANS, HAS DEVELOPED A REPORT THAT SUMMARIZES SAFETY AND EFFECTIVENESS DATA ON 67 PATIENTS WHO UNDERWENT HAND SURGERY AT CCF BETWEEN 2008 AND 2023 UTILIZING DEPUY SYNTHES (DPS) HAND PLATES. IMPLANTS INVOLVED WERE LCP COMPACT HAND PLATES OR VA LOCKING HAND SYSTEM. 3 PATIENTS WERE NOTED TO HAVE MORE THAN ONE PLATE IMPLANTED. DPS SCREWS WERE INVOLVED. PATIENT #(B)(6) 58-YEAR-OLD MALE WAS IMPLANTED WITH A VA LOCKING HAND PLATES (02.130.366) WITH 6 SCREWS AND VA LOCKING HAND SYSTEM (02.130.355) WITH 7 SCREWS. POST OP COMPLICATION WAS REPORTED FOR MALROTATION AND MALUNION OF LEFT 4TH METACARPAL SHAFT FRACTURE. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. THERE IS NO DEVICE FAILURE NOTED. TREATMENT: 1. REMOVAL OF DEEP HARDWARE, LEFT HAND. 2. CORRECTIVE OSTEOTOMY, LEFT 4TH METACARPAL SHAFT. THIS REPORT IS FOR A 2.0MM VAL CONDYLAR PLATE 2 HOLES HD-6 HOLES SHAFT. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Deformity/ Disfigurement; Malunion of Bone

  MAUDE report 19088390 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO DISCOMFORT. THE DEVICES EXPLANTED WERE ONE (1) 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PLATE, ONE (1) 2.0MM VAL CONDYLAR PLATE, TWO (2) 3.5MM CORTEX SCREWS, FOUR (4) 2.7MM VA LOCKING SCREWS AND FIVE (5) 2.0MM VA LOCKING SCREWS. ALL IMPLANTS WERE REMOVED INTACT AND BONE HAD SUCCESSFULLY HEALED. THIS REPORT IS FOR ONE (1) 2.0MM VAL CONDYLAR PLATE 2 HOLES HD-6 HOLES SHAFT. THIS IS REPORT 2 OF 13 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort

  MAUDE report 14142061 ↗