NA 02.130.354Recalls & reported problems
Synthes GmbH · 2.0MM VAL PHALANGEAL BASE PL 2 HOLES HD-6 HOLES SHAFT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982045393), received between Apr 11, 2024 and Apr 11, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Synovitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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, DR. , 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 #13 44-YEAR-OLD FEMALE WAS IMPLANTED WITH A VA LOCKING HAND PLATES (02.130.354) WITH 6 SCREWS. TWO ADDITIONAL ADJUNCTIVE FIXATION SCREWS WAS USED FOR FRACTURE FIXATION. POST OP COMPLICATION WAS REPORTED FOR SYMPTOMATIC RIGHT HAND HARDWARE & RESULTING RIGHT LONG FINGER MP JOINT SYNOVITIS. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. TREATMENT: RIGHT HAND DEEP HARDWARE REMOVAL THIS REPORT IS FOR ONE 2.0 VAL PHALANG BASE PL 2 H HD-6H SFT. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).
Patient problems: Synovitis
MAUDE report 19088935 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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