NA 324.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982190918), received between Apr 15, 2021 and Aug 10, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497540 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, ONE PELVIC REDUCTION FORCEP, ONE LISS INSERTION GUIDE FOR DISTAL FEMUR, ONE DEPTH GAUGE FOR LOCKING SCREW, FOUR UNIVERSAL CHUCK WITH T-HANDLE, ONE CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, ONE PELVIC REDUCTION FORCEP, TWO RIA DRIVE SHAFT, ONE BENDING PLIERS, ONE FORCEP FOR BROKEN SCREW REMOVAL, ONE LOCKING PLIER, TWO LARGE QUICK COUPLING, ONE DEPTH GAUGE, ONE SILICONE HANDLE, ONE RED FORCEPS SERRATED JAW RATCHET, ONE PLATE HOLDING FORCEP, ONE REDUCTION FORCEP WITH POINT RATCHET, ONE HOLDING SLEEVE WITH WING SCREW, ONE GRAPHIC CASE AND TWO GRAPHIC CASE FOR SCREW REMOVAL SET WERE BROKEN FROM USAGE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE DISTAL FEMUR LISS INSERTION GUIDE-LEFT. THIS IS REPORT 2 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584418 ↗
• InjuryApr 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE THERE WAS A WEAR AND TEAR OF FIXATION BOLT FOR LESS INVASIVE STABILIZATION SYSTEM (LISS) INSERTION GUIDE AND THE LISS INSERTION GUIDE WAS ALSO UNABLE TO BE FULLY SECURED DUE TO INABILITY TO TIGHTEN SUCCESSFULLY DUE TO STRIPPING DURING TIGHTENING. THERE WAS A TWENTY (20) MINUTES OF SURGICAL DELAY AS SURGEON HAD TO DO A LONGER INCISION FOR A VERY LONG PLATE INSTEAD OF USING A MINIMAL INVASIVE JIG. PATIENT OUTCOME IS REPORTED AS LONGER INCISION TO RECOVER FROM. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) DISTAL FEMUR LISS INSERTION GUIDE-LEFT THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11674787 ↗