PINNACLE 2217-01-047Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295097587), received between Oct 2, 2020 and Jun 21, 2021 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 12035595 ↗
• 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) P1." NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035534 ↗
• 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 12035492 ↗
• 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 12033762 ↗
• 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 12033755 ↗
• 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 12033737 ↗
• MalfunctionOct 2, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE SIZE AND PART NUMBER OF THE TRIALS WERE WORN OFF. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10622204 ↗