NA 292.699Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982180834), received between Sep 18, 2019 and Feb 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5114313. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT IS FOR ONE (1) 2.0MM KIRSCHNER WIRE THREADED SPADE POIN THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368840 ↗
• MalfunctionOct 18, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A KIRSCHNER WIRE WAS RECEIVED BENT WITHIN THE PACKAGE. IT WAS BELIEVED THAT THE REPORTED DEVICE WAS ALREADY DEFECTIVE BEFORE IT WAS SHIPPED SINCE THE PACKAGE THAT HOUSES THE ITEM WAS NOT DAMAGED. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) 2.0MM KIRSCHNER WIRE THREADED SPADE POINT TIP 280MM. THIS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9210680 ↗
• MalfunctionSep 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A KIRSCHNER WIRE THREADED SPADE POINT WAS RECEIVED BENT FOR RESTOCK. IT WAS ORDERED RESTOCK FROM A CASE THE DAY BEFORE AND RECEIVED THE ITEM THE NEXT DAY. WHEN TOOK IT OUT TO RESTOCK THE SET IT WAS NOTICED AS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.0 MM KIRSCHNER WIRE THREADED SPADE POINT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9084254 ↗