PINNACLE 2217-01-057Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295097686), received between Jun 6, 2019 and Jan 31, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WAS A STRIPPED TRIAL AND IMPACTOR. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21283914 ↗
• 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 12036492 ↗
• 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 12036451 ↗
• 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 12036377 ↗
• 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 12034573 ↗
• 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 12034390 ↗
• 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 12033992 ↗
• MalfunctionJun 6, 2019Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS ON THE 57/58MM CUP TRIAL WERE DAMAGED UPON REMOVAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675792 ↗