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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

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