NA 02.130.254Recalls & reported problems
Synthes GmbH · 1.5MM VAL PHALANGEAL BASE PL 2 HOLES HD-6 HOLES SHAFT · Class 2 · Implant
Data updated Oct 16, 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 10886982044839), received between Apr 12, 2024 and Apr 12, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Adhesion(s)1
- Loss of Range of Motion1
- Muscular Rigidity1
- Scar Tissue1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
POST MARKET STUDY REPORTED, 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 #15 33-YEAR-OLD FEMALE WAS IMPLANTED WITH A VA LOCKING HAND PLATES (02.130.254) WITH 6 SCREWS. POST OP COMPLICATION WAS REPORTED FOR PERSISTENT SIGNIFICANT L LONG FINGER STIFFNESS; LIMITED ROM DUE TO EXTENSOR TENDON ADHESION; POSSIBLE IRRITATION/SCAR TISSUE FORMATION DUE TO HARDWARE. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. THERE IS NO DEVICE FAILURE NOTED TREATMENT: 1) HARDWARE REMOVAL FROM LEFT MIDDLE FINGER 2) EXTENSOR TENOLYSIS OF LEFT MIDDLE FINGER, DORSUM OF HAND AND FINGER (CPT: 26445) 3) FLEXOR TENOLYSIS OF LEFT MIDDLE FINGER, PALM AND FINGER (CPT:26442) THIS REPORT IS FOR ONE 1.5MM VAL PHALANGEAL BASE P
Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity; Scar Tissue; Skin Inflammation/ Irritation
MAUDE report 19097230 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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