PINNACLE 2218-36-454Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295101369), received between Jul 18, 2017 and Sep 25, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  It was reported that while trialing the liner the liner trial broke. All pieces were retrieved. No harm to patient. There was delay to the procedure. No additional information is available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897025 ↗
• MalfunctionMay 12, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION. THIS EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150001 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHILE TESTING THE TEST COMPONENTS, THE DEVICE BROKE AT THE CONNECTING SCREW. IT WAS REPORTED THAT THIS DID NOT CAUSE ANY DELAYS, AS IT COULD BE USED UNDER THESE CONDITIONS, ALLOWING THE SURGERY TO BE COMPLETED SUCCESSFULLY, WITHOUT DISCOMFORT FOR THE SPECIALIST, WITHOUT AFFECTING THE PATIENT, AND WITHOUT ALTERING THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25041833 ↗
• MalfunctionMar 10, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE IS REPORTED DUE TO WEAR AND TEAR OVER THE YEARS. IT DID NOT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560179 ↗
• MalfunctionMar 10, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE IS REPORTED DUE TO WEAR AND TEAR OVER THE YEARS. IT DID NOT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560172 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED THAT THE TRIAL LINER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234486 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT THE TRIAL LINER HAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836516 ↗
• MalfunctionJun 23, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PINNACLE TRIAL LINERS WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190029 ↗
• MalfunctionFeb 16, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS THE CENTRAL PART THAT HAD THE SCREW THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385615 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625662 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625538 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625519 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625483 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625342 ↗
• MalfunctionOct 6, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE INSTRUMENT IS OLD AND WEATHERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15553952 ↗
• MalfunctionNov 18, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED AS "TRIALS IN POOR CONDITION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836639 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL BROKE AWAY FROM THE METAL SCREW WHEN IS WAS INSERTED. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527454 ↗
• MalfunctionJun 11, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE LINERS APPEARS TO HAVE CRACKS AND SCRATCHES IN VARIOUS PLACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982336 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED THAT GRATERS HAVE THE CROSSBACK ATTACHMENT BROKEN OFF. POLY TRIALS HAVE THE SCREWS CRACKED OFF AT THE DOME. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979702 ↗
• MalfunctionMay 21, 2021Break; Break

  IT WAS REPORTED AS "BROKEN IN STERILIZATION". NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864120 ↗
• MalfunctionMay 5, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT THE LINERS APPEARS TO HAVE CRACKS AND SCRATCHES IN VARIOUS PLACES. NO SURGICAL DELAYS OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777685 ↗
• MalfunctionMar 16, 2021Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS WERE REPORTED DUE TO CORROSION AND WEAR. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497429 ↗
• MalfunctionFeb 23, 2021Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT GRATER CASE IS BENT WHERE HANDLES FIT AND REAMER HANDLES ARE DROPPING IN AND WONT COME OUT DEPTH GAUGE IS BENT AND TIP IS UNUSABLE POLY TRIALS HAVE THE SCREWS BROKEN OFF AT THE DOME AND CAN¿T BE READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369002 ↗
• MalfunctionFeb 23, 2021Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT GRATER CASE IS BENT WHERE HANDLES FIT AND REAMER HANDLES ARE DROPPING IN AND WONT COME OUT DEPTH GAUGE IS BENT AND TIP IS UNUSABLE POLY TRIALS HAVE THE SCREWS BROKEN OFF AT THE DOME AND CAN¿T BE READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11368978 ↗
• MalfunctionFeb 16, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SCREWS HAVE BROKEN OFF OF THE LINER TRIALS. THE SCREWDRIVER IS ROUNDED OFF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334618 ↗