PINNACLE 2217-60-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295424161), received between Jun 8, 2018 and Aug 12, 2026 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227816 ↗
• MalfunctionAug 7, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50172917 ↗
• MalfunctionOct 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT'S TIP WAS WORN AND MAL-SHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328454 ↗
• MalfunctionMay 28, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: THE PATIENT WAS UNDER ANESTHETIC FOR LONGER THAN NECESSARY (APPROX 45 MINS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403614 ↗
• MalfunctionNov 23, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT BOTH INSTRUMENTS HAVE THE TIPS BENT AND SHEARED OFF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851235 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED THAT THE TIP OF THE TWO INSTRUMENTS WERE BROKE OFF. IT WAS FOUND IN THE SETS, AND WERE NOT USED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10898197 ↗
• MalfunctionNov 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THEY NOTICED THAT THE TIP WAS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10839072 ↗
• InjuryJun 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  I DON'T HAVE THE DETAILS YET ON SOME OF THE PRODUCTS INVOLVED, PINN CUP AND CERAMIC INSERT AND HEAD. IT WAS A REVISION AND THEY HAD MAJOR PROBLEMS REMOVING CERAMIC INSERT. THEY TRIED THE ALTERNATIVE BEARINGS REMOVING INSTRUMENT, THE SMALL CERAMIC EXTRACTOR AND NOTHING WORKED. THEY SPEND AT LEAST AN HOUR TRYING TO REMOVE THE INSERT. THEY EVEN CALLED ME FROM THE OR TO VERIFY IF THEY WERE USING THE RIGHT INSTRUMENTS AND TECHNIQUE, BUT NOTHING WORKED. THEY FINALLY TRIED TO CUT THE CERAMIC INSERT WITH A MIDASREX DIAMOND BURR WITH NO RESULTS. THEY FINALLY OPTED TO TRY TO REMOVE THE CUP WITH THE INSERT STILL IN IT USING ZIMMER'S EXPLANT INSTRUMENT. WHILE TAPPING ON THE HANDLE, THE CERAMIC INSERT FINALLY CRACKED AND THEY WERE ABLE TO REMOVE IT. A T HANDLE WAS ALSO BROKEN DURING THIS CASE, PART OF THE TIP BROKE, DUE TO WEAR. ALSO A CERAMIC EXTRACTOR TIP WAS DAMAGED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7583073 ↗