LCP 03.108.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982071606), received between Apr 14, 2021 and Sep 1, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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.

• MalfunctionSep 1, 2026Break; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546476 ↗
• MalfunctionNov 24, 2025Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE WRENCHES IN THE PEDIATRIC HIP SET WOULD NOT GRIP THE LOCKING TOWERS TO INSERT INTO THE PLATES. APPEARED TO BE STRIPPED/ROUNDED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23637483 ↗
• MalfunctionNov 24, 2025Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE WRENCHES IN THE PEDIATRIC HIP SET WOULD NOT GRIP THE LOCKING TOWERS TO INSERT INTO THE PLATES. APPEARED TO BE STRIPPED/ROUNDED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23637469 ↗
• MalfunctionApr 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED VIA EMAIL FROM THE HEALTHCARE PRACTITIONER (HCP) THAT, ON (B)(6) 2021 HE HAD A PROBLEM WITH THE 3 DRILL SLEEVE THAT COULD HARDLY BE TURNED INTO THE ANGULAR STABLE THREADED HOLES OF THE 130¿ HIP PLATE 5.0, NEITHER AT THE PROXIMAL END FOR THE FEMORAL NECK SCREWS NOR DISTALLY FOR THE SHAFT SCREWS. THIS WAS PARTICULARLY PROBLEMATIC PROXIMALLY AFTER PLACEMENT OF THE FEMORAL NECK WIRES. IT COULD BE A THREAD MISMATCH HERE OR THE THREADS OF THE DRILL SLEEVES ARE NO LONGER GOOD. IN ADDITION, THE DRILL SLEEVES ARE DIFFICULT TO HANDLE AND SCREW IN WITH WET FINGERS (IF YOU HAVE FOUND THE CORRECT DIRECTION), ALSO THE KEY GRIPS POORLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 4.3MM THREADED DRILL GUIDE FOR 5.0MM PEDIATRIC LCP HIP PL THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667057 ↗
• MalfunctionApr 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED VIA EMAIL FROM THE HEALTHCARE PRACTITIONER (HCP) THAT, ON MARCH 16,2021 HE HAD A PROBLEM WITH THE 3 DRILL SLEEVE THAT COULD HARDLY BE TURNED INTO THE ANGULAR STABLE THREADED HOLES OF THE 130° HIP PLATE 5.0, NEITHER AT THE PROXIMAL END FOR THE FEMORAL NECK SCREWS NOR DISTALLY FOR THE SHAFT SCREWS. THIS WAS PARTICULARLY PROBLEMATIC PROXIMALLY AFTER PLACEMENT OF THE FEMORAL NECK WIRES. IT COULD BE A THREAD MISMATCH HERE OR THE THREADS OF THE DRILL SLEEVES ARE NO LONGER GOOD. IN ADDITION, THE DRILL SLEEVES ARE DIFFICULT TO HANDLE AND SCREW IN WITH WET FINGERS (IF YOU HAVE FOUND THE CORRECT DIRECTION), ALSO THE KEY GRIPS POORLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 4.3MM THREADED DRILL GUIDE FOR 5.0MM PEDIATRIC LCP HIP PL THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11666490 ↗
• MalfunctionApr 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED VIA EMAIL FROM THE HEALTHCARE PRACTITIONER (HCP) THAT, ON MARCH 16,2021 HE HAD A PROBLEM WITH THE 3 DRILL SLEEVE THAT COULD HARDLY BE TURNED INTO THE ANGULAR STABLE THREADED HOLES OF THE 130° HIP PLATE 5.0, NEITHER AT THE PROXIMAL END FOR THE FEMORAL NECK SCREWS NOR DISTALLY FOR THE SHAFT SCREWS. THIS WAS PARTICULARLY PROBLEMATIC PROXIMALLY AFTER PLACEMENT OF THE FEMORAL NECK WIRES. IT COULD BE A THREAD MISMATCH HERE OR THE THREADS OF THE DRILL SLEEVES ARE NO LONGER GOOD. IN ADDITION, THE DRILL SLEEVES ARE DIFFICULT TO HANDLE AND SCREW IN WITH WET FINGERS (IF YOU HAVE FOUND THE CORRECT DIRECTION), ALSO THE KEY GRIPS POORLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 4.3MM THREADED DRILL GUIDE FOR 5.0MM PEDIATRIC LCP HIP PL. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11666009 ↗