PINNACLE 2217-01-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295097655), received between Sep 10, 2018 and May 6, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 8 most recent of 8 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 25093779 ↗
• 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 25085250 ↗
• MalfunctionJun 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GRATER HANDLE DOES NOT ALLOW HANDLE TO CLOSE, THE REAMERS AND THE INSTRUMENTS ARE DULL AND THE TRIAL IS CROSS THREADED. THE EVENT DID NOT HAPPEN DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365390 ↗
• 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 21181530 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE SIZE 54 PINNACLE CUP TRIAL THREADS WERE STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452779 ↗
• MalfunctionJun 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CROSS THREADS IN THE CUP PREVENTED THE PINNACLE HANDLE FROM SCREWING IN COMPLETELY. THE HANDLE HAD NO DAMAGE, JUST THE CUP TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106628 ↗
• MalfunctionSep 13, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT BOTH INSTRUMENTS BROKE OR WERE DAMAGED DURING THIS CASE AND NEED TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9034463 ↗
• MalfunctionSep 10, 2018Difficult to Remove; Difficult to Remove

  PRODUCT CODE: 221750041 AND 221701054, LOT/BATCH/EXP: SHELL ONLY J0109. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? NEW SET OPENED TO INSERT CUP. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? 2 MIN DELAY. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: 2 HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: INSERTER HANDLE THREAD GOT STUCK TO THE TRIAL SHELL AND COULDN¿T BE SEPARATED.

  Patient problems: Not Applicable

  MAUDE report 7859575 ↗