NA 292.10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20886982180312), received between Jul 1, 2019 and May 23, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT SEVERAL PACKAGES OF K-WIRES WERE RECEIVED WITH BENT WIRES. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078617 ↗
• MalfunctionMay 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT SEVERAL PACKAGES OF K-WIRES WERE RECEIVED WITH BENT WIRES. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078581 ↗
• MalfunctionMay 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT SEVERAL PACKAGES OF K-WIRES WERE RECEIVED WITH BENT WIRES. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078550 ↗
• MalfunctionMay 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT SEVERAL PACKAGES OF K-WIRES WERE RECEIVED WITH BENT WIRES. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078511 ↗
• MalfunctionMay 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT SEVERAL PACKAGES OF K-WIRES WERE RECEIVED WITH BENT WIRES. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078506 ↗
• MalfunctionJul 22, 2022Tear, Rip or Hole in Device Packaging; Material Deformation; Tear, Rip or Hole in Device Packaging; Material Deformation

  IT WAS REPORTED THAT TWO (2) KIRSCHNER WIRES WITH TROCAR POINT WERE RECEIVED WITH OPEN PACKAGE. IT WAS NOTICED DURING INSPECTION THAT THE PACKAGE WAS COMPRESSED (END-TO-END) AND THERE WAS A HOLE IN THE PLASTIC AT ONE END. UPON OPENING, IT WAS DISCOVERED THAT (2) OF THE WIRES WERE BENT AND UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089750 ↗
• MalfunctionJul 22, 2022Tear, Rip or Hole in Device Packaging; Material Deformation; Tear, Rip or Hole in Device Packaging; Material Deformation

  IT WAS REPORTED THAT TWO (2) KIRSCHNER WIRES WITH TROCAR POINT WERE RECEIVED WITH OPEN PACKAGE. IT WAS NOTICED DURING INSPECTION THAT THE PACKAGE WAS COMPRESSED (END-TO-END) AND THERE WAS A HOLE IN THE PLASTIC AT ONE END. UPON OPENING, IT WAS DISCOVERED THAT (2) OF THE WIRES WERE BENT AND UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089700 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS DISCOVERED THAT THE KIRSCHNER WIRE WITH TROCAR POINT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8750794 ↗