NA 02.130.255SRecalls & reported problems
Synthes GmbH · 1.5MM VAL CONDYLAR PLATE 2H HEAD-6H SHAFT-STERILE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982044860), received between Jun 4, 2018 and Apr 12, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Operates Differently Than Expected1
Patient problems
- Adhesion(s)2
- Muscular Rigidity2
- Loss of Range of Motion1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 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
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 #(B)(6) 47-YEAR-OLD FEMALE WAS IMPLANTED WITH A VA LOCKING HAND PLATES (02.130.255S) WITH 5 SCREWS AND VA LOCKING HAND SYSTEM (02.130.255S) WITH 5 SCREWS POST OP COMPLICATION WAS REPORTED FOR PERSISTENT STIFFNESS TO FLEXION; FLEXOR AND EXTENSOR ADHESIONS. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. THERE IS NO DEVICE FAILURE NOTED. TREATMENT: RIGHT RING AND SMALL FINGER HARDWARE REMOVAL, EXTENSOR AND FLEXOR TENOLYSIS. THIS REPORT IS FOR A 1.5MM VAL CONDYLAR PLATE 2H HEAD-6H SHAFT-STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).
Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity
MAUDE report 19096414 ↗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 #32 47-YEAR-OLD FEMALE WAS IMPLANTED WITH A VA LOCKING HAND PLATES WITH 5 SCREWS AND VA LOCKING HAND SYSTEM WITH 5 SCREWS. POST OP COMPLICATION WAS REPORTED FOR PERSISTENT STIFFNESS TO FLEXION; FLEXOR AND EXTENSOR ADHESIONS. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. THERE IS NO DEVICE FAILURE NOTED. TREATMENT: RIGHT RING AND SMALL FINGER HARDWARE REMOVAL, EXTENSOR AND FLEXOR TENOLYSIS. THIS REPORT IS FOR ONE (1) 1.5MM VAL CONDYLAR PLATE 2H HEAD-6H SHAFT-STERILE. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4). THIS COMPLAINT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.
Patient problems: Adhesion(s); Muscular Rigidity
MAUDE report 19093431 ↗InjuryJun 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, WHILE ATTEMPTING TO IMPLANT THE 1.5MM VARIABLE ANGLE LOCKING (VAL) CONDYLAR PLATE, SURGEON ATTEMPTED TO INSERT THREE (3) DIFFERENT LOCKING SCREWS INTO ONE OF THE HOLES OF THE PLATE, BUT WAS NOT ABLE TO LOCK THEM TO THE PLATE. SURGEON USED A CORTEX SCREW IN PLACE OF THE LOCKING SCREW. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) 1.5MM VAL CONDYLAR PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 7567562 ↗
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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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