PINNACLE 2217-01-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295097631), received between Aug 8, 2019 and May 6, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE, IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. THE TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094197 ↗
• MalfunctionMay 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE. THE IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY, AND THE TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. IT WAS REPORTED THAT THERE WAS NO SIGNIFICANT DELAY, AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085214 ↗
• MalfunctionJun 11, 2025Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT THE DEVICE WAS SCRATCHED AND DENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188145 ↗
• MalfunctionJan 17, 2025Material Discolored; Material Deformation; Illegible Information; Material Discolored; Material Deformation; Illegible Information

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE SIZE INDICATION LASER ETCHING ON THE APEX SOME ITEMS HAD BECOME EXTREMELY WORN AND FADED; IT WAS INCREDIBLY DIFFICULT TO READ CLEARLY. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181565 ↗
• MalfunctionMar 29, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS IN THE TRIAL CUP WERE STRIPPED AND THE CUP NO LONGER SCREWS ON TO IMPACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585858 ↗
• MalfunctionAug 8, 2019Corroded; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Corroded; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  AFTER SURGERY WITHIN MULTIPLE HOSPITAL, IN 4 ORTHOKITS WE HAVE FOUND OUT THAT THE XXX ARE HAVE OXIDATED AROUND THE INCAVED LETTERS AND NUMBERS WHEN DID THE DEVICE PROBLEM OCCUR? AFTER USING THE ORTHOKITS FOR SURGERY. SOME HAS RUST, SOME HAS NOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8873635 ↗