PINNACLE 2217-01-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295097570), received between Jan 24, 2022 and May 21, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SHELL WOULD NOT THREAD ON HANDLE. THE CASE WAS NOT AFFECTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059269 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SHELL WOULD NOT THREAD ON HANDLE. THE CASE WAS NOT AFFECTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059266 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SHELL WOULD NOT THREAD ON HANDLE. THE CASE WAS NOT AFFECTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059265 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SHELL WOULD NOT THREAD ON HANDLE. THE CASE WAS NOT AFFECTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059263 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SHELL WOULD NOT THREAD ON HANDLE. THE CASE WAS NOT AFFECTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059261 ↗
• MalfunctionJan 24, 2022Naturally Worn; Naturally Worn

  PARTS ARE STRIPPED AND WOULD NOT SCREW TOGETHER. NO FRAGMENTS PRODUCED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338594 ↗
• MalfunctionJan 24, 2022Naturally Worn; Naturally Worn

  PARTS ARE STRIPPED AND WOULD NOT SCREW TOGETHER. NO FRAGMENTS PRODUCED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338524 ↗