VA-LCP 03.231.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982077318), received between Apr 10, 2018 and May 21, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 22066345 ↗
• MalfunctionNov 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DISTAL FEMUR FRACTURE FIXATION CASE, THE AIMING ARM WAS NOT ACCURATELY TARGETING THE SCREWS INTO THE HOLES IN THE PLATE. THE AIMING ARM AND INSERTION HANDLE NEEDED TO BE REPLACED. THE SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/RIGHT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754496 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE (1) AIMING ARM FOR VA-LCP CONDYLAR PLATE AND (1) HANDLE WAS BROKEN AFTER AN UNKNOWN PROCEDURE. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559587 ↗
• MalfunctionNov 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AIMING ARM WOULDN¿T THREAD INTO THE INSERTION HANDLE. THE SURGEON USED EXCESSIVE FORCE TO TRY AND FORCE THE AIMING ARM TO THREAD INTO THE INSERTION HANDLE, WHICH EVENTUALLY LED TO THE TWO ITEMS BECOMING STUCK TOGETHER. THE AIMING ARM AND INSERTION HANDLE COULD NO LONGER BE USED. THE SURGEON THEN PERFORMED A LARGE OPEN INCISION, AS HE WAS NO LONGER ABLE TO DO THE PROCEDURE MINIMALLY INVASIVE BECAUSE OF THE PRODUCT FAULT. THIS REPORT INVOLVES ONE (1) AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795712 ↗
• MalfunctionDec 2, 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 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10935717 ↗
• 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: 03.231.003, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/ RIGHT. THIS IS REPORT 2 OF 3 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Code Available

  MAUDE report 10066555 ↗
• 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 10026510 ↗
• MalfunctionNov 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN (B)(6) 2019, DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR, AN AIMING ARM ATTACHMENT MALFUNCTIONED DURING A CASE AND DID NOT LINE UP CORRECTLY. THE AIMING ARM WAS NOT USED IN THE PROCEDURE. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9291906 ↗
• MalfunctionMar 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, UPON INSPECTION IN THE STERILE PROCESSING DEPARTMENT (SPD), TWO (2) COUPLING BOLTS APPEARED TO HAVE DAMAGE TO THE STARTING THREADS, AND THE DEVICES COULD NOT BE SCREWED INTO THE AIMING ARM. IT WAS NOTED THAT THE THREADS ON THE AIMING ARM WERE ALSO DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A AIMING ARM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8399193 ↗
• InjuryDec 31, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE SAME DEVICE WAS USED PRE-OPERATION AND DURING OPERATION, BUT THE DEVICE WAS NOT DEFECTIVE DURING PRE-OPERATION INSTRUMENT ASSEMBLY. A LARGER INCISION WAS REQUIRED TO INSERT SHAFT SCREWS ALONG THE FEMUR. THIS WAS BECAUSE THE AIMING ARM OF THE PERCUTANEOUS DEVICE WAS DEFECTIVE, THEREFORE STAB INCISIONS COULD NOT BE USED TO INSERT SHAFT SCREWS (WHICH IS THE MAIN PURPOSE OF THE AIMING ARM FOR THE PERCUTANEOUS INSTRUMENTATION).

  Patient problems: No Code Available

  MAUDE report 8205992 ↗
• 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/ RIGHT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199840 ↗
• MalfunctionApr 10, 2018Break; Break

  REPORT FROM DEVICE SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT TRAY WAS OPENED FOR A CASE. DURING ASSEMBLY OF THE NECESSARY DEVICES, THE SCRUB NURSE ACCIDENTALLY ATTACHED THE AIMING ARM INCORRECTLY THUS CAUSING THE INSTRUMENT TO BE UNUSABLE. THE AIMING ARM AND THE BOLT BROKE DURING THE INTRAOPERATIVE ASSEMBLY. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE TEAM REVERTED TO USING THEIR BACK UP SYSTEM TO COMPLETE THE PROCEDURE. A 40 MINUTE SURGICAL DELAY WAS REPORTED. NO PATIENT HARM REPORTED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412313 ↗

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