VA-LCP 03.231.007Recalls & reported problems

Synthes GmbH · LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM · Class 2

All models of VA-LCP (256)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Synthes aiming arm is used with the VA-LCP condylar plate to fix fractures at the lower end of the femur. The 56 reports mostly describe parts that no longer snap or lock into place properly, along with bent and stripped threading that left instruments unusable, and cases where a trocar would not fit into other guide sleeves. Reports mention no deaths and no injuries, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 56
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10886982077349), received between Sep 13, 2018 and Dec 8, 2025 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (51 reports).

2 other recalls cover devices cleared under the same FDA submission (K110354); 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device-Device Incompatibility51
Material Twisted/Bent12
Material Deformation2
Mechanical Jam2
Break1

Patient problems

No Clinical Signs, Symptoms or Conditions37
No Consequences Or Impact To Patient12
No Code Available6
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2025, TROCAR W/HANDLE, WOULD NOT INTERFACE WITH SEVERAL GUIDE SLEEVES. THERE WAS NO DELAY TO SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744115 ↗
MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2025, TROCAR W/HANDLE, WOULD NOT INTERFACE WITH SEVERAL GUIDE SLEEVES. THERE WAS NO DELAY TO SURGERY. SURGERY WAS COMPLETE SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742641 ↗
MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2025, TROCAR W/HANDLE, WOULD NOT INTERFACE WITH SEVERAL GUIDE SLEEVES. THERE WAS NO DELAY TO SURGERY. SURGERY WAS COMPLETE SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742568 ↗
MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2025, TROCAR W/HANDLE, WOULD NOT INTERFACE WITH SEVERAL GUIDE SLEEVES. THERE WAS NO DELAY TO SURGERY. SURGERY WAS COMPLETE SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742507 ↗
MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2025, TROCAR W/HANDLE, WOULD NOT INTERFACE WITH SEVERAL GUIDE SLEEVES. THERE WAS NO DELAY TO SURGERY. SURGERY WAS COMPLETE SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742462 ↗
MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2025, TROCAR W/HANDLE, WOULD NOT INTERFACE WITH SEVERAL GUIDE SLEEVES. THERE WAS NO DELAY TO SURGERY. SURGERY WAS COMPLETE SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742242 ↗
MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786663 ↗
MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786660 ↗
MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786659 ↗
MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786656 ↗
MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786655 ↗
MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786654 ↗
MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786653 ↗
MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786651 ↗
MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE IN 2025, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786647 ↗
MalfunctionAug 6, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DISTAL FEMUR WITH THE SURGEON, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS A SURGICAL DELAY BUT NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726560 ↗
MalfunctionMay 30, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THE INSERTS FOR CURVED CONDYLAR AIMING ARM GETS JAMMED AND STUCK UPON INSERTION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22116631 ↗
MalfunctionMay 30, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THE INSERTS FOR CURVED CONDYLAR AIMING ARM GETS JAMMED AND STUCK UPON INSERTION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22116463 ↗
MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE LOCKING/NEUTRAL GUIDE FOR THE 4.5MM VA LCP CURVED CONDYLAR PLATE WAS MALFUNCTIONING AND WOULD NOT LOCK INTO PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM. THIS IS REPORT 9 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15914318 ↗
MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE LOCKING/NEUTRAL GUIDE FOR THE 4.5MM VA LCP CURVED CONDYLAR PLATE WAS MALFUNCTIONING AND WOULD NOT LOCK INTO PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM. THIS IS REPORT 10 OF 10 FOR PC-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15914315 ↗
MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE LOCKING/NEUTRAL GUIDE FOR THE 4.5MM VA LCP CURVED CONDYLAR PLATE WAS MALFUNCTIONING AND WOULD NOT LOCK INTO PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM. THIS IS REPORT 8 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15914314 ↗
MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE LOCKING/NEUTRAL GUIDE FOR THE 4.5MM VA LCP CURVED CONDYLAR PLATE WAS MALFUNCTIONING AND WOULD NOT LOCK INTO PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM. THIS IS REPORT 7 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15914309 ↗
MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE LOCKING/NEUTRAL GUIDE FOR THE 4.5MM VA LCP CURVED CONDYLAR PLATE WAS MALFUNCTIONING AND WOULD NOT LOCK INTO PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR A LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM. THIS IS REPORT 6 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15914305 ↗
MalfunctionDec 2, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE LOCKING/NEUTRAL GUIDE FOR THE 4.5MM VA LCP CURVED CONDYLAR PLATE WAS MALFUNCTIONING AND WOULD NOT LOCK INTO PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM. THIS IS REPORT 2 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15911266 ↗
MalfunctionDec 2, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE LOCKING/NEUTRAL GUIDE FOR THE 4.5MM VA LCP CURVED CONDYLAR PLATE WAS MALFUNCTIONING AND WOULD NOT LOCK INTO PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM. THIS IS REPORT 1 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15910826 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110354. One submission often covers many models, so check the product and lot details in each record.

Z-1125-2014 · Feb 5, 2014 · Terminated
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
Z-0401-2014 · May 29, 2013 · Terminated
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra

Device details

UDI-DI	`10886982077349`
Brand	VA-LCP
Model	03.231.007
Catalog no.	03231007
Company	Synthes GmbH
Product code	JDP · condylar plate fixation Implant
Class	Class 2
FDA submission	K110354
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 21, 2022

Device type (GMDN): Orthopaedic implant aiming arm

A surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

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All condylar plate fixation Implant devices →

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.

How reports and recalls are matched · Editorial policy · Report an error on this page