NA 323.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982190567), received between Nov 4, 2021 and Mar 18, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE STRIPPED, WON¿T CONNECT ON QC. THERE WAS NO PATIENT STATUS CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633773 ↗
• MalfunctionMar 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE STRIPPED, WON¿T CONNECT ON QC. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620813 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE THE INSTRUMENTS WERE FOUND BROKEN IN STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345819 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE THE INSTRUMENTS WERE FOUND BROKEN IN STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345737 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE THE INSTRUMENTS WERE FOUND BROKEN IN STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345543 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929129 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929126 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON JULY 14, 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929125 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929124 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON JULY 14, 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929123 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929120 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON JULY 14, 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929117 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON JULY 14, 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929115 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON JULY 14, 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929112 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT ON JULY 14, 2024, THE ITEM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT POSTOPERATIVELY. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928077 ↗
• MalfunctionFeb 14, 2022Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT ON UNKNOWN DATE IN 2022, A PATIENT UNDERWENT AN UNKNOWN PROCEDURE. IT WAS NOTED THAT A K-WIRE GOT STUCK AND BENT IN THE K-WIRE SLEEVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. NO PATIENT CONSEQUENCES NOTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE 1.6MM WIRE SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525943 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SIX (6) DEPTH GAUGES, ONE (1) SPINDLE NUT, ONE (1) WIRE SLEEVE, ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT, AND ONE (1) UNIVERSAL CHUCK WERE BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 1.6MM WIRE SLEEVE. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751948 ↗