PINNACLE 2218-28-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295100171), received between Jul 1, 2019 and Sep 30, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT BROKE IN 2 PIECES AT THE EDGE OF THE LINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12557631 ↗
• MalfunctionMay 13, 2020Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  DURING THE COVID PERIOD, HOSPITAL STAFF AT (B)(6) EXAMINED A VARIETY OF SETS AND CAME ACROSS SEVERAL DAMAGED INSTRUMENTS (7 TOTAL) IN THEIR PINNACLE BANTAM SET THAT REQUIRE REPLACING: THE PINNACLE IMPACTOR ADAPTER AND SHELL TRIAL WERE CROSS THREADED AND NO LONGER USABLE (221750048 & 221701038). THE 28MM LINER IMPACTOR WAS GAUGED (221750006). THE ARTICULEZE TRIAL BALLS AND NEUTRAL TRIAL LINERS WERE ALSO GAUGED AND NOT USABLE DUE TO WEAR AND TEAR (253070000, 253069000, 221828044 & 221828046). ALL ITEMS WERE DISCARDED. NO PATIENT OPERATING ROOM INTRA-OP ISSUES AS THIS DID NOT OCCUR IN THE OPERATING ROOM. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053903 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WERE NOT USED IN SURGERY. THEY WERE FOUND BROKEN IN SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750318 ↗