PINNACLE 2217-01-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295097679), received between Jul 5, 2017 and May 6, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 15 most recent of 15 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 25094145 ↗
• 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 25085315 ↗
• 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 21181574 ↗
• MalfunctionOct 30, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE PINNACLE STRAIGHT IMPACTOR AND 56 TRIAL CUP CROSS THREADED AND FUSED TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 18029438 ↗
• MalfunctionMar 28, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THE SCREW THREAD IS DAMAGED AND NOT CONNECTING TO IMPACTOR HANDLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632807 ↗
• MalfunctionFeb 24, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ARE CROSS THREADED FOR THE CUP IMPACTOR ON 56 CUP TRIAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436466 ↗
• MalfunctionAug 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PINNACLE CUP INSERTER HANDLE IS CROSS THREADED ONTO THE 56MM CUP TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358065 ↗
• MalfunctionNov 5, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE CUP THREADS BECAME CROSS THREADED AND THE CUP TRIAL WAS USED BUT DIFFICULT TO REMOVE FROM THE WHITE PINNACLE CUP INSERTED. THE CASE WAS NOT DELAYED AND THE HANDLE THREADS WHERE CHECKED AND ARE IN DAMAGED, BUT THE CUP THREADS ARE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10792823 ↗
• MalfunctionApr 22, 2020Material Twisted/Bent; Material Twisted/Bent

  THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON FOUND IN THE OFFICE SET. NO SURGERY WAS AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986621 ↗
• 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 8873632 ↗
• 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 8873629 ↗
• MalfunctionAug 7, 2019Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE 56 CUP TRIAL THREADS WERE DAMAGED CAUSING THE TRIAL TO NOT PROPERLY ENGAGE WITH THE CUP INSERTION HANDLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869359 ↗
• MalfunctionDec 19, 2018Naturally Worn; Naturally Worn

  THE SHELL TRIAL WOULD NOT THREAD ONTO ANY OF THE HANDLES. I BELIEVE IT HAS BEEN CROSS THREADED. NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180994 ↗
• MalfunctionJun 5, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TWO CROSS THREADED PINNACLE HANDLES SNAP RING ON 56 X 4 NEUTRAL TRIAL LINER DISENGAGED. IT WAS ALSO INDICATED THAT THE TRIAL CUP (56 MM) HAD DAMAGED THREADS. SURGICAL DELAY OF 2 MINS.

  Patient problems: Not Applicable

  MAUDE report 7568634 ↗
• MalfunctionJul 5, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON JUNE 21, 2017 - UPON EVALUATION OF THE RETURNED INSTRUMENT FOUND THE DAMAGE TO THE TRIAL DEEP GOUGES WITH SMALL PIECES OF MATERIAL MISSING. (B)(6). ON JUNE 28, 2017: IT WAS REPORTED THAT THE CUP TRIAL WAS DAMAGED DURING SURGERY AND NOW HAS A SHARP EDGE ON IT.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6687542 ↗