NA 02.130.252Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982044792), received between Jul 3, 2018 and Apr 12, 2024 — classified as 3 injuries, 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 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

  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 #19 42-YEAR-OLD MALE WAS IMPLANTED WITH A VA LOCKING HAND PLATES (02.130.252) WITH 6 SCREWS. ONE ADDITIONAL ADJUNCTIVE FIXATION BIOMATERIALS WAS USED FOR COMMINUTION / BONE LOSS POST OP COMPLICATION WAS REPORTED FOR PERSISTENT RIGHT SMALL FINGER METACARPOPHALANGEAL JOINT POSTTRAUMATIC STIFFNESS, LIMITED ROM. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. THERE IS NO DEVICE FAILURE NOTED. TREATMENT: REMOVAL OF RIGHT FIFTH METACARPAL PLATES AND SCREWS AND EXTENSOR TENOLYSIS, AND DORSAL METACARPOPHALANGEAL JOINT CAPSULOTOMY. THIS REPORT IS FOR A 1.5MM VAL T-PLATE 3 HOLES HD-7 HOLES SHAFT. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 19101087 ↗
• 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 (B)(6) 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 #31 31-YEAR-OLD FEMALE WAS IMPLANTED WITH A VA LOCKING HAND PLATES (02.130.252) WITH 6 SCREWS POST OP COMPLICATION WAS REPORTED FOR PERSISTENT PAIN. TREATMENT: LEFT THUMB CARPOMETACARPAL JOINT ARTHROSCOPY WITH DEBRIDEMENT AND THERMAL CAPSULAR SHRINKAGE; LEFT THUMB CMC JOINT PERCUTANEOUS PINNING ; LEFT THUMB DEEP HARDWARE REMOVAL WITH CARPOMETACARPAL ARTHROPLASTY THIS REPORT IS FOR ONE (1) 1.5MM VAL T-PLATE 3 HOLES HD-7 HOLES SHAFT THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 19093294 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HAND PLATES IN COLLABORATION WITH DEPUY SYNTHES DOCTORS, 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. THE IMPLANTS INVOLVED WERE LCP COMPACT HAND PLATES OR VA LOCKING HAND SYSTEM. THREE (3) PATIENTS WERE NOTED TO HAVE MORE THAN ONE PLATE IMPLANTED WHERE DPS SCREWS WERE INVOLVED. PATIENT #34, A 20-YEAR-OLD MALE WAS IMPLANTED WITH A VA LOCKING HAND PLATES (02.130.252) WITH THREE (3) SCREWS. ONE ADDITIONAL ADJUNCTIVE FIXATION EXTERNAL FIXATOR (DPS) WAS USED FOR FIXATION / STABILIZATION. POST OP COMPLICATION WAS REPORTED FOR PERSISTENT LIMITED ROM IN FLEXION AT MCP JOINT. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. THERE IS NO DEVICE FAILURE NOTED. TREATMENT: 1. LEFT, MIDDLE FINGER METACARPAL PHALANGEAL JOINT CAPSULOTOMY. 2. LEFT MIDDLE FINGER, EXTENSOR TENOLYSIS. 3. LEFT MIDDLE FINGER, MANIPULATION UNDER ANESTHESIA. 4. LEFT MIDDLE FINGER, REMOVAL OF RETAINED HARDWARE. THIS

  Patient problems: Loss of Range of Motion

  MAUDE report 19091673 ↗
• MalfunctionNov 1, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS CLARIFIED THAT THE LOCKING SCREW IS WHAT WAS BENT. THE PLATE WAS NOT BENT. IT WAS NOTED THERE WAS A TWO (2) MINUTE SURGICAL DELAY. THE SURGEON LEFT ONE LOCKING SCREW IN DESPITE NOT LOCKING INTO THE PLATE.

  Patient problems: No Code Available

  MAUDE report 9268182 ↗
• MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2018, THE DISTAL RIGHT HOLE OF THE VARIABLE ANGLE LOCKING (VAL) T-PLATE DID NOT LOCK WITH A CORTEX SCREW. THE CORTEX SCREW WAS ALREADY FULL SEATED ON THE PLATE AND THE SURGEON SPUN THE SCREW IN CIRCLES WITHOUT THE LOCKING MECHANISM ENGAGING. THE CORTEX SCREW WAS PULLED OUT AND WAS REUSED ON ANOTHER HOLE AND WAS ABLE TO LOCK SUCCESSFULLY. AS PER CONSULTANT, THERE WAS NOTHING WRONG WITH THE SCREW. THE SURGEON RE-DRILLED THE PATH TO TRY THE CORTEX SCREW AGAIN AND IT DID NOT LOCK UPON THE SECOND TIME. A PROPER DRILL GUIDE WAS ALSO USED DURING THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF THREE (3) MINUTES. PATIENT'S STATUS IS STABLE. CONCOMITANT DEVICES REPORTED: 1.5MM CORTEX SCREW SELF-TAPPING WITH T4 STARDRIVE RECESS 12MM (PART: 02.214.112, LOT: UNKNOWN, QUANTITY: 1), 1.1MM VA LOCKING DOUBLE DRILL GUIDE/FREEHAND/1.5MM VAL PLATE (PART: 03.130.221, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A 1.5MM VAL T-PLATE 3 HOLES HD-7 HOLES SHAFT. THIS IS REPORT 1OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7660375 ↗