PINNACLE 2217-01-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295097754), received between Jul 31, 2019 and May 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Corroded” (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 5 most recent of 5 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 25093703 ↗
• 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 21181541 ↗
• MalfunctionAug 17, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A LOANER SET OF INSTRUMENTS WAS RECEIVED BACK FROM A HOSPITAL THAT CONTAINED RESIDUAL DEBRIS AND HAD TO BE RETURNED TO THE SITE FOR ADDITIONAL CLEANING BY THEIR STERILE PROCESSING DEPARTMENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10417547 ↗
• MalfunctionAug 2, 2019Corroded; Device Contamination with Chemical or Other Material; Corroded; Device Contamination with Chemical or Other Material

  DESCRIBE EVENT: 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. IS THIS REPORT RELATED TO A PIECE OF CAPITAL EQUIPMENT? YES. DID THE EVENT OCCUR DURING A PROCEDURE/SURGERY? NO. PROCEDURE/SURGERY NAME ARTHROPLASTY? PROCEDURE/SURGERY DATE N/A, MULTI HOSPITALS HAS USED IT? WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE ? ALL THE GRATER HEADS IN DIFFERENT SIZES WHICH SHOW OXIDATION AROUND THE LETTERS/NUMBERS WILL BE REPLACED,BUT ARE IN BACK ORDER FOR A LONG TIME. WE CANNOT USE THE KITS FOR SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8857292 ↗
• MalfunctionJul 31, 2019Corroded; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Corroded; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  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 8846396 ↗