PINNACLE 2217-01-059Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295097709), received between Jun 23, 2020 and Aug 19, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2020Material Twisted/Bent; Naturally Worn; Illegible Information; Material Twisted/Bent; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE SIZING ON THE TRIALS CAN'T BE READ. NUMBER ETCHING WERE WORN OFF. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS.

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

  MAUDE report 10426871 ↗
• MalfunctionJun 23, 2020Corroded; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Corroded; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn

  PRIOR TO THR CASE, SCRUB NURSE IDENTIFIED DAMAGED SZ 59 PINNACLE SHELL TRIAL THREAD DAMAGED. WOULD NOT ENGAGE WITH PINNACLE STRAIGHT INSERTER HANDLE DUE TO DAMAGED THREAD. ANOTHER PINNACLE SHELL TRIAL TRAY WAS OPENED FOR THE SIZE 59 PINNACLE SHELL TRIAL FOR CASE. CASE WENT AHEAD AND WENT WELL. DID THE EVENT OCCUR DURING STERILE PROCESSING? NO, DID THE EVENT OCCUR DURING FIELD INSPECTION? NO, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184629 ↗