Watson Extraction System 17501Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00197169175011), received between May 1, 2025 and Sep 25, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902750 ↗
• MalfunctionSep 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595485 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT THE DOCTOR USED WATSON EXTRACTION SYSTEM TO REMOVE STEM WITH STRIKE PLATE ATTACHMENT. IT WAS REPORTED THAT THE DEVICE WAS USED TO MANUFACTURERS SPECIFIC CAUTIONS, AND THE STRIKE PLATE BROKE OFF THE THREADED EXTRACTION HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377125 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT THE WATSON SLAP HAMMER AND T-HANDLE THREADS SHEARED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23978082 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT THE WATSON SLAP HAMMER AND T-HANDLE THREADS SHEARED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23978021 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT WATSON EXTRACTOR HANDLE AND THREADED T HANDLE BROKE WHILE EXTRACTING THE STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23495424 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT THE PIECES WERE BROKEN WHILE TRYING TO DISASSEMBLE. THERE WAS NO PATIENT CONSEQUENCE AND NO DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329225 ↗
• MalfunctionAug 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF THE CONTENTS OF A WATSON EXTRACTION CONSIGNMENT TRAY BY STERILE PROCESSING PERSONNEL, A WATSON EXTRACTOR HANDLE THREADED TIP WAS FOUND BROKEN OFF INSIDE OF THE WATSON THREADED HANDLE. IT IS UNKNOWN WHEN, WHERE, OR HOW THE HANDLE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865389 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT THE THREADS OF THE THREADED T-HANDLE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22590577 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE BROKEN WATSON EXTRACTION INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384257 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153849 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE THREADED T-HANDLE IS CROSS THREADED ONTO THE EXTRACTOR HANDLE AND WON'T COME OFF. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944014 ↗