PINNACLE 2217-01-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295097495), received between May 13, 2020 and May 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 OR INTRA-OP ISSUES AS THIS DID NOT OCCUR IN THE OR. (B)(4). IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053545 ↗