VA-LCP 03.231.006Recalls & reported problems
Synthes GmbH · NUT FOR INTERLCKING BOLT F/VA LCP CONDYLAR INSERTN HANDLE · Class 2
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982077332), received between Sep 24, 2021 and Apr 7, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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
Most reported problems
Device problems
- Device-Device Incompatibility6
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Device-Device Incompatibility
IT WAS REPORTED THAT AIMING ARM WAS DISCONNECTING FROM PLATE. REAMER WAS TOO DULL AND KEPT GETTING INCARCERATED IN THE BONE. SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802657 ↗MalfunctionApr 7, 2026Device-Device Incompatibility
IT WAS REPORTED THAT AIMING ARM WAS DISCONNECTING FROM PLATE. REAMER WAS TOO DULL AND KEPT GETTING INCARCERATED IN THE BONE. SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802647 ↗MalfunctionMay 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE AIMING ARM FOR 4.5 VA CURVED CONDYLAR SET WAS NOT LINING UP WITH THE PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066330 ↗MalfunctionJan 25, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A KNEE SURGERY ON (B)(6) 2024, THE THREAD OF THE NUT DIDN'T WORK, AND THE NUT COULDN'T FIX INTO THE AIMING ARM. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A NUT FOR INTERLOCKING BOLT F/VA LCP CONDYLAR INSERT HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18579621 ↗MalfunctionDec 3, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, DURING STERILIZATION PROCESS OF A ROUTINE FIELD INSPECTION, THE BOLT DOES NOT TIGHTEN ONTO INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) NUT INTRLCK BOLT VA LCP COND INSRTN HNDL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12927185 ↗MalfunctionSep 24, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT, WHEN THE CURVED CONDYLAR PLATE AND THE AIMING ARM WAS ATTACHED, IT WAS NOT ABLE TO ATTACH DUE TO THE STRIPPAGE OF THE SCREW HOLE OF THE PLATE. WHILE USING THE AIMING ARM ON THE NEW UNKNOWN PLATE, THE NEUTRAL SLEEVES WERE NOT CONNECTING TO THE HARPOON. THE PEDIATRIC AIMING ARM WAS OUTRIGGER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH (10) MINUTES DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) NUT FOR INTERLCKING BOLT F/VA LCP CONDYLAR INSERTN HANDLE. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12525839 ↗
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 · TerminatedSynthes 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 · TerminatedSynthes 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
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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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