PINNACLE 2218-40-460Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295101543), received between Jan 31, 2018 and Nov 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. BROKEN 60 +4 NEUTRAL LINER NOT ABLE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617856 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 20667537 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL BROKE INTO THREE PIECES WHILE REMOVING FROM PATIENT. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19350290 ↗
• MalfunctionOct 13, 2021Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628163 ↗
• MalfunctionOct 13, 2021Break; Break

  IT WAS REPORTED AS "BROKEN. LINER TRIAL DAMAGE AND SCREW WON'T STAY IN LINER. GRATER WAS BROKEN DURING STERILIZATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628072 ↗
• MalfunctionJul 2, 2019Break; Material Disintegration; Detachment of Device or Device Component; Break; Material Disintegration; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CENTER METAL PIECE OF LINER TRIAL HAS FALLEN OUT. THIS DID NOT OCCUR DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752906 ↗
• MalfunctionJan 29, 2019Break; Break

  CENTER THREADED METAL PART OF ES3 60 MM +4 NEUTRAL LINER BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285964 ↗
• MalfunctionMay 31, 2018Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL WAS REMOVED AND THE RETENTION CLIP CAME OFF AND WAS LOST. TOOK AN X-RAY AND VERIFIED IT WASN¿T LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556468 ↗
• MalfunctionJan 31, 2018Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THE OFFSET IMPACTOR BROKE AND WOULD NOT UNSCREW FROM THE CUP. WHEN TRIED TO UNSCREW THE TRIAL LINER IT CAME APART AS WELL. SURGICAL DELAY OF 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7230573 ↗