VA-LCP 03.231.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982077301), received between Mar 27, 2017 and Jan 30, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE HOLE #10 OF THE AIMING ARM WOULD NOT HOLD THE OUTER TROCAR SLEEVE. MULTIPLE SLEEVES WERE TRIED. THE ITEM DID NOT APPEAR TO BE BROKEN. THE PROCEDURE SUCCESSFULLY COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 21274993 ↗
• MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A NAIL PLATE COMBO, VA CONDYLAR AIMING ARM WAS USED. THE CORTICAL SCREW MISSED THE PLATE. THERE WAS A DELAY IN SURGERY DUE TO HAVING TO FREEHAND. THERE WAS 3 MINUTES OF SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) AIM ARM FOR 4.5 VA-LCP CRVD COND PL/RT THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785285 ↗
• MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A NAIL PLATE COMBO, VA CONDYLAR AIMING ARM WAS USED. THE CORTICAL SCREW MISSED THE PLATE. THERE WAS A DELAY IN SURGERY DUE TO HAVING TO FREEHAND. THERE WAS 3 MINUTES OF SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) AIM ARM FOR 4.5 VA-LCP CRVD COND PL/LFT THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785274 ↗
• MalfunctionDec 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2020, AN AIMING ARM LEFT NOT LINING UP WITH PLATE HOLES WHEN THEY HAVE A PLATE ATTACHED TO THE INSERTION HANDLE, AIMING ARM RIGHT NOT LINING UP WITH PLATE HOLES WHEN THEY HAVE A PLATE ATTACHED TO THE INSERTION HANDLE, AND INSERTION HANDLE SEEMS TO BE OUT OF SINK WITH BOTH AIMING ARMS. IT IS WAS DISCOVERED DURING AN INSPECTION. THERE WAS NO PATIENT INVOLVEMENT THIS COMPLAINT INVOLVES 3 DEVICES. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10943270 ↗
• InjuryMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AIMING ARM WAS NOT LINING UP WITH THE TOP HOLE ON THE INSERTION HANDLE FOR CURVED CONDYLAR PLATE WHILE THE SURGEON WAS ATTEMPTING TO USE IT. THE SURGEON STATED THAT THIS HAS HAPPENED FOUR TIMES AND THE AIMING ARMS WERE NOT LINING UP AND A BIGGER INCISION WAS MADE TO ACCESS THE PROXIMAL HOLE. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: 4.5MM VA LCP CONDYLAR PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), INSERTION HANDLE (PART: 03.231.001, LOT: UNKNOWN, QUANTITY: 1), AIMING ARM (PART: 03.231.004, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/ LEFT. THIS IS REPORT 3 OF 3 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4) .

  Patient problems: No Code Available

  MAUDE report 10066606 ↗
• InjuryMay 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE AIMING ARM BOTH RIGHT AND LEFT AIMING ARM WERE DEFECTIVE IT WAS NOT LINING UP WITH THE TOP HOLE ON THE INSERTION HANDLE FOR CURVED CONDYLAR PLATE WHILE THE SURGEON WAS ATTEMPTING TO USE IT.

  Patient problems: No Code Available

  MAUDE report 10026511 ↗
• MalfunctionApr 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MAR 21, 2019 DURING AN UNKNOWN PROCEDURE, THE AIMING ARM INSTRUMENT AND PLATE DID NOT ALIGN ACCURATELY. THE INSERTION HANDLE, INTERLOCKING BOLT, AND SIX (6) LOCKING NEUTRAL GUIDE WERE USED TO HELP STABILIZE A PLATE AND AIMING ARM TO ALLOW THE SURGEON TO DO THE PROCEDURE PERCUTANEOUSLY. THE PLATE WAS IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511667 ↗
• MalfunctionDec 27, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON (B)(6) 2018, THE ARM SLEEVES OF LEFT AND RIGHT AIMING ARM WERE NO LONGER LOCKING SECURELY IN THE GUIDE. THE GROOVES IN THE CARBON FIBER OF THE AIMING ARMS SEEM TO BE WEARING OUT, PREVENTING THE METAL WINGS IN THE SLEEVES FROM ENGAGING. THE TROCAR WITH HANDLE WAS NOT PROPERLY LOCKING INTO THE SLEEVES DURING THE SLEEVE INSERTION TO AIMING ARM. THE CASE WAS COMPLETED SUCCESSFULLY BY MANUALLY HOLDING THE SLEEVES IN THE AIMING ARM DURING THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM. CONCOMITANT DEVICES: GUIDE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A AIMING ARM FOR 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE/LEFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199724 ↗
• MalfunctionMar 27, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT A SYNTHES SALES CONSULTANT WAS PERFORMING AN IN-SERVICE DEMONSTRATION FOR A SURGEON AND DURING THE DEMONSTRATION THE SALES CONSULTANT EXPERIENCED AN ISSUE WITH THE DISTAL FEMORAL DEVICES NOT ALIGNING CORRECTLY WITH THE PLATE. THE SALES CONSULTANT ASSEMBLED ALL THE PARTS WHICH CONSISTED OF AN INTERLOCKING BOLT, A NUT FOR THE INTERLOCKING BOLT, AIMING ARM, INSERTION HANDLE AND A 4.5MM VARIABLE ANGLE CONDYLAR PLATE, 8 HOLE, LEFT. THE DEMONSTRATION DEVICES WERE USED AS FOLLOWS: THE INSERTION HANDLE GOES ONTO THE PLATE; THE INTERLOCKING BOLT GOES THROUGH THE INSERTION HANDLE AND LOCKS ONTO THE PLATE; THE NUT TIGHTENS DOWN ON THE INSERTION HANDLE; AND THE AIMING ARM LOCKS ONTO THE INSERTION HANDLE. THE NUT AND THE INTERLOCKING BOLT WOULD NOT ALIGN CORRECTLY ONTO THE INSERTION HANDLE. THE SALES CONSULTANT REMOVED THE NUT AND INTERLOCKING BOLT AND USED A DIFFERENT NUT AND A DIFFERENT INTERLOCKING BOLT WITH THE SAME INSERTION HANDLE AND THEY WOULD NOT ALIGN CORRECTLY, HENCE, THE AIMING ARM WOULD NOT ALIGN WITH THE HOLES ON THE PLATE. THE SALES CONSULTANT WAS UNABLE TO GET THE DEVICES TO ALIGN CORRECTLY, HOWEVER THE SURGEON UNDERSTOOD THE CONCEPT OF HOW THE DEVICES FUNCT

  Patient problems: No Patient Involvement

  MAUDE report 6435967 ↗

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