LCP 03.113.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982072696), received between Dec 31, 2020 and Mar 12, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS INSIDE THE INSERTION HANDLE ARE CROSS-THREADED. THE KNOB CANNOT BE SCREWED IN PROPERLY TO SECURE THE INSERTION HANDLE ON THE AIMING ARM. THIS REPORT IS FOR ONE (1)A ARM 3.5 LCP LOW BND MED DSTL TIB PL/RT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885411 ↗
• MalfunctionMar 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE THREADS INSIDE THE INSERTION HANDLE ARE CROSS-THREADED. THE KNOB CANNOT BE SCREWED IN PROPERLY TO SECURE THE INSERTION HANDLE ON THE AIMING ARM. THIS REPORT IS FOR ONE (1)A ARM 3.5 LCP LOW BND MED DSTL TIB PL/RT THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885406 ↗
• MalfunctionDec 27, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED ON UNKNOWN EVENT DATE THAT THE KNOB ON THE RIGHT MEDIAL DISTAL TIBIA AIMING ARM (REMOVED PRODUCT CODE) IS BENT AND STUCK IN THE JIG HINDERING IT FROM ATTACHING TO THE PLATE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) A ARM 3.5 LCP LOW BND MED DSTL TIB PL/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399285 ↗
• MalfunctionApr 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE AIMING ARM FOR THE LOCKING COMPRESSION (LCP) LOW BEND MEDIAL DISTAL TIBIA PLATE WAS NOT LINING UP WITH THE PLATE PROPERLY. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AIMING ARM F/3.5MM LCP LOW BND MEDIAL DISTAL TIBIA PL/RIGHT. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610368 ↗
• MalfunctionMar 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 WHILE INSERTING A DISTAL TIBIA PLATE, THE AIMING ARM WAS MISSING THE PROXIMAL HOLES. AFTER THE CASE IT WAS DETERMINED THAT THERE WAS AN ISSUE WITH THE AIMING ARM AND IT IS POSSIBLE THAT THE RIGHT SIDE AIMING ARM WAS EITHER DAMAGED/BENT. ONCE THE PROBLEM WAS IDENTIFIED, THE SURGERY PROCEEDED AND WAS SUCCESSFULLY FINISHED. THE SURGERY WAS DELAYED FOR FIFTEEN (15) MINUTES. THIS REPORT IS FOR ONE (1) AIMING ARM F/3.5MM LCP LOW BND MEDIAL DISTAL TIBIA PL/RIGHT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474882 ↗
• MalfunctionDec 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN LCP MEDIAL DISTAL TIBIA INTERNAL FIXATION WITH JIG PROCEDURE, THE AIMING ARM AND INSERTION HANDLE DID NOT ALIGN WITH LCP HOLES. THE SURGEON WAS UNABLE TO USE THESE INSTRUMENTS FOR PERCUTANEOUS INSERTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN TIBIAL PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) AIMING ARM F/3.5MM LCP LOW BND MEDIAL DISTAL TIBIA PL/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102196 ↗