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
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 ↗
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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.
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