PINNACLE 2217-00-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295097310), received between Mar 23, 2018 and Sep 10, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722441 ↗
• MalfunctionNov 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE PINNACLE EXTRACTION SET WAS USED TODAY, AND IT LOOKS AS THOUGH A COUPLE OF THE ITEMS ARE BROKEN. THE FEET ARE MISSING.

  Patient problems: Insufficient Information

  MAUDE report 18169368 ↗
• MalfunctionJul 7, 2021Break; Break

  AT LEAST ON OF THE TIPS OF EACH OF THE AB EXTRACTOR IS BROKEN . UNKNOWN CIRCUMSTANCES, ISSUE RAISED BY STERILE SERVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129951 ↗
• MalfunctionMar 23, 2018Break; Break

  THIS INSTRUMENT COMPLAINT IS LINKED TO REVISION SURGERY (B)(4). (B)(6) HOSPITAL - (B)(6) 2018. AB EXTRACTOR LUG BROKE WHEN ATTEMPTING TO REMOVE CERAMIC LINER. DEVICE INEFFECTIVE IN REMOVAL. CERAMIC REMOVED VIA ALTERNATIVE MEANS. HIP REVISED. NO PATIENT ISSUE RELATING TO PRODUCT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7365201 ↗