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VA-LCP 03.127.009Recalls & reported problems

Synthes GmbH · AIMING ARM FOR 3.5MM VA-LCP PROXIMAL TIBIA PLATE · Class 2

All models of VA-LCP (256)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982075093), received between Jul 23, 2021 and Dec 20, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Device-Device Incompatibility2
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 20, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    THE SURGERY WAS COMPLETED SUCCESSFULLY, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18366136 ↗
  • MalfunctionSep 8, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) TIBIAL PLATEAU AND ORIF ANKLE PROCEDURE. THE AIMING ARM FOR THE VA PROXIMAL TIBIA PLATE SET WAS DROPPED ON THE FLOOR AND BROKE. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT AND SURGERY WAS NOT DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE FRAGMENTS GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. NO PATIENT CONSEQUENCES NOTED. THIS REPORT INVOLVES (1) AIMING ARM FOR 3.5MM VA-LCP PROXIMAL TIBIA PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12441290 ↗
  • MalfunctionSep 7, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, THE AIMING ARM FOR THE VA PROXIMAL TIBIA PLATE SET WAS DROPPED ON THE FLOOR AND WAS BROKEN. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT AND SURGERY WAS NOT DELAYED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)AIM ARM FOR 3.5 VA-LCP PROXIMAL TIBIA PL. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12433166 ↗
  • MalfunctionJul 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN UNPACKING A SET, I WAS ATTEMPTING TO REMOVE THE KNOB HANDLE FROM AN AIMING ARM. THE KNOB DID NOT WANT TO COME OUT OF THE AIMING ARM. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) AIM ARM FOR 3.5 VA-LCP PROXIMAL TIBIA PL. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12220913 ↗

Other PLATE, FIXATION, BONE devices

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Sources and updates

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