PINNACLE 2217-01-049Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295097600), received between Jun 21, 2021 and Jun 17, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TECH WAS SETTING UP AND WENT TO PUT THE TEMPLATED TRIAL ON THE CUP IMPACTOR. THE 49/50 TRIAL CUP IN THE PINNACLE CORE WAS JUST OPENED AND IT WOULD NOT SCREW ONTO THE HANDLE ALL THE WAY. IT LOOKED LIKE ONE OF THE THREADS WAS SLIGHTLY BENT. THERE WAS NO DELAY TO THE CASE, AS ANOTHER TRAY AVAILABLE. NO ISSUE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555006 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED AS "CAN¿T READ SIZES ON TRIALS (WORN OFF). SEND REPLACEMENTS TO (B)(6).". NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036134 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED AS "CAN¿T READ SIZES ON TRIALS (WORN OFF). SEND REPLACEMENTS TO (B)(6)." NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035668 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED AS "CAN¿T READ SIZES ON TRIALS (WORN OFF). SEND REPLACEMENTS TO (B)(6)." NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035605 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED AS "CAN¿T READ SIZES ON TRIALS (WORN OFF). NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033842 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED AS "CAN'T READ SIZES ON TRIALS (WORN OFF). NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033829 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED AS "CAN'T READ SIZES ON TRIALS (WORN OFF). NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033793 ↗