PINNACLE 2217-01-055Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295097662), received between Oct 2, 2020 and Apr 4, 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 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.

• MalfunctionApr 4, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT WHITE IMPACTOR HANDLE COLD WELDED/CROSS THREADED INTO A ACETABULAR TRIAL SHELL. A DEPUY SYNTHES PRODUCT BROKE DURING SURGERY AND ALL PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 21777309 ↗
• 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 12036352 ↗
• 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 12036304 ↗
• 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 12036262 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  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 12034712 ↗
• 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 12034583 ↗
• 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 12033923 ↗
• 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 10622177 ↗