NA 395.923Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982200945), received between Aug 13, 2018 and Mar 18, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 16, 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 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY WERE DOING EXTRA-LARGE EXTERNAL FIXATOR CASE WITH HA COAT UPON INSERTION HA COAT THROUGH THE SLEEVE THEY GOT CUT INSIDE. THE PATIENT WAS NOT AFFECTED, AND SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-LONG THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924612 ↗
• MalfunctionSep 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SLEEVE IS BENT AND WEDGED SHANZ PIN. IT IS UNABLE TO SPECTATE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-LONG THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836495 ↗
• MalfunctionSep 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SLEEVE IS BENT AND WEDGED SHANZ PIN. IT IS UNABLE TO SPECTATE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836224 ↗
• MalfunctionMay 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THE ITEMS IN QUESTION WERE DISCOVERED, TO BE BENT AND DAMAGED. THIS WAS OBSERVED, POST-OP WHILE THE ITEMS WERE BEING CLEANED IN STERILE PROCESSING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 6.0MM/5.0MM THREADED DRILL SLEEVE-LONG. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007187 ↗
• MalfunctionMay 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THE ITEMS IN QUESTION WERE DISCOVERED TO BE BENT AND DAMAGED. THIS WAS OBSERVED, POST-OP WHILE THE ITEMS WERE BEING CLEANED IN STERILE PROCESSING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 6.0MM/5.0MM THREADED DRILL SLEEVE-LONG. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007186 ↗
• MalfunctionAug 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A SCREW WAS STUCK IN A LONG-THREADED DRILL SLEEVE. IT WAS FOUND OUT AT THE STERILE PROCESSING DEPARTMENT ON (B)(6) 2018. THERE WAS NO PATIENT AND PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7778610 ↗