NA 394.43Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982199713), received between Sep 4, 2018 and Nov 20, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE ON AN (B)(6) 2025, THE COMPONENTS OF THE LARGE DISTRACTOR NO LONGER HELD THE DISTRACTIONS; THEY KEPT SLIPPING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605668 ↗
• MalfunctionSep 4, 2018Device-Device Incompatibility; Device-Device Incompatibility

  (B)(6) REPORTS FOLLOWING: IT WAS REPORTED THAT DURING STERILE PROCESSING DEPARTMENT (SPD) INSPECTION ON AN UNKNOWN DATE, THE SLIDING CARRIAGE WAS NOTED TO BE CROSS THREADED AND SEIZED ON TWO (2) HOLDING SLEEVES AND A SCHANZ SCREW BLUNTED TROCAR. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURING INVESTIGATION, THE CONDITION OF TWO DEVICES BEING STUCK TOGETHER WAS CONFIRMED, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THIS REPORT IS FOR ONE (1) SLIDING CARRIAGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841673 ↗