LCP 247.360Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982170828), received between Sep 23, 2019 and Apr 12, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K063049); they may or may not involve this specific model.

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 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) 20-YEAR-OLD FEMALE WAS IMPLANTED WITH A LCP COMPACT HAND PLATES / MODULAR MINI FRAGMENT SYSTEM (247.36) WITH 6 SCREWS. FOUR ADDITIONAL ADJUNCTIVE FIXATION WIRE + BIOMATERIALS WAS USED FOR FIXATION / BONE LOSS. POST OP COMPLICATION WAS REPORTED FOR PERSISTENT LIMITED ROM (FLEXION) AT MCP JOINT. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. THERE IS NO DEVICE FAILURE NOTED. TREATMENT: 1. HARDWARE REMOVAL OF RIGHT 3RD METACARPAL BONE (PLATE AND SCREWS) 2. HARDWARE REVISION OF RIGHT 4TH METACARPAL BONE (SHORTENING OF PLATE) 3. APPLICATION OF BONE GRAFT/BONE SUBSTITUTE TO RIGHT 4TH METACARPAL FRACTURE NON-UNION SITE 4. EXTENSOR TENOLYSIS OF

  Patient problems: Loss of Range of Motion

  MAUDE report 19095688 ↗
• InjuryMay 22, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO BROKEN PLATE AND NON-UNION. NON-UNION WAS TREATED WITH 2.7MM VARIABLE ANGLE LOCKING COMPRESSION OLECRANON PLATE PLUS AUTOGRAFT. FRAGMENTS WERE GENERATED FROM A BROKEN DEVICE AND WERE REMOVED EASILY. THE ORIGINAL DATE OF THE IMPLANT WAS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS NON-UNION. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2) UNKNOWN CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 4). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10082289 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT HARDWARE REMOVAL OF OLECRANON DUE TO INFECTION AND INFLAMMATION. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TITANIUM FUSION PLATE 3 HOLES, ONE (1) LOCKING COMPRESSION PLATE 10 HOLES, 0NE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE 6 HOLES, TWO (2) CORTICAL SCREWS, ONE (1) LOCKING SCREW, EIGHT (8) VARIABLE ANGLE LOCKING SCREWS, THREE (3) 2.7 CORTEX SCREWS AND TWO (2) CORTEX SCREWS WERE REMOVED. ALL HARDWARE WAS INTACT. THE ORIGINAL IMPLANT DATE WAS ON (B)(6) 2018, WITH OPEN REDUCTION AND INTERNAL FIXATION (ORIF) FOR A GUNSHOT WOUND. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS COMPLETE AND STABLE. THIS IS REPORT 2 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9105342 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063049. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen