PINNACLE 2217-50-088Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295520627), received between Dec 8, 2021 and Nov 16, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE LINER EXTRACTOR TIP AND DURALOC IMPACTOR TIP ARE CROSS THREADED AND CANNOT BE SEPARATED. NO TIME WAS ADDED TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148870 ↗
• MalfunctionOct 11, 2022Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT DURING ROUTINE PROCESSING, THE MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE TIP OF THE COMPLAINED ITEM WAS BADLY DAMAGED: THE TIP WAS JAGGED AND ROUGH WITH GOUGES, SCRATCHES AND BLEMISHES. THE MDR STAFF DEEMED THE INSTRUMENT TO BE NO LONGER FUNCTIONAL, AND IT WAS SUBSEQUENTLY DISCARDED. A REPLACEMENT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579476 ↗
• MalfunctionDec 8, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS OF THE PINNACLE DM THR LINER EXTRACTOR WERE CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961133 ↗