Kelly-Wick Tunneler KW2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741129452), received between Oct 26, 2020 and Jul 3, 2026 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 3, 2026Tear, Rip or Hole in Device Packaging; Material Twisted/Bent

  On (b)(6) 2026, a patient underwent surgical procedure using a Kelly Wick Tunneller. Prior to the procedure, it was reported that there was bent on latch and holes in the internal plastic. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702331 ↗
• MalfunctionJul 3, 2026Tear, Rip or Hole in Device Packaging; Material Twisted/Bent

  On (b)(6) 2026, a patient underwent surgical procedure using a Kelly Wick Tunneller. Prior to the procedure, it was reported that there was bent on latch and holes in the internal plastic. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702323 ↗
• MalfunctionOct 26, 2020Component Missing; Component Missing

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL KW2000 TUNNELER SET ALLEGEDLY EXPERIENCED COMPONENT MISSING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10734871 ↗