PINNACLE 2218-40-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295430018), received between Oct 20, 2020 and Oct 23, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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.

• MalfunctionOct 23, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SCREWDRIVER AND LINER THREADS STRIPPED, AND THE USER COULD NOT GET THE LINER TO THREAD INTO CUP. SCREWDRIVERS AND TRIAL WERE VERY WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372662 ↗
• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157874 ↗
• MalfunctionSep 27, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE LINER TRIAL WAS SCUFFED WHEN REMOVING WHEN TRIALING. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20325579 ↗
• MalfunctionJan 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. ADDITIONAL INFORMATION PER INVESTIGATIONAL FINDINGS: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PIN TRL LNR NEUT 40IDX56OD HAS SIGNS OF SCRATCHES AT THE SURFACE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES, LIKE USAGE OF FORCEPS, TWEEZERS, SHARP TOOLS, ETC. WHILE TRIALING. ADDITIONALLY THE SNAP RING AND THE SCREW WERE MISSING, IT IS TO POSSIBLE THAT THESE TWO COMPONENTS WERE MOST LIKELY DISASSEMBLED DUE TO OVER TIGHTENING. HOWEVER THE POTENTIAL CAUSE FOR THE MISSING SCREW AND RING CANNOT BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18520487 ↗
• MalfunctionDec 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LINER TRIAL DOES NOT SCREW INTO CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934764 ↗
• MalfunctionNov 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE LINER TRIALS FOR THE SIZE 40 WERE NOT SEATING PROPERLY. SURGEON REQUESTS NEW SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12898619 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT THE FOLLOWING INSTRUMENTS ARE DAMAGED AND NEEDS TO REPLACED. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896052 ↗
• MalfunctionNov 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LINER TRIAL WOULDN'T SEAT IN THE CUP AND THE SURGEON ASKED TO GET A SET IN THAT WOULD WORK. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883244 ↗
• MalfunctionOct 20, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS ON THE EXTERIOR OF THE LINER TRIAL THAT SCREW INTO THE CUP FOR TRIALING WERE CROSS THREADED. LINER NO LONG SITS FLUSH IN THE CUP FOR TRIALING. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10707724 ↗