HAT-TRICK 72204370Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554034943), received between Oct 27, 2017 and Aug 17, 2022 — classified as 1 injury, 1 malfunction.

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

• InjuryAug 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING USE, WHEN INSERTING THE PROXIMAL PORTION OF THE PIP IMPLANT, THE IMPLANT SHEARED IN HALF AND BROKE OFF WHILE PART OF IT WAS STILL IN THE PATIENT AND IT WAS UNABLE TO BE REMOVED FROM THE BONE. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE ON THE SURGICAL TECHNIQUE; TOE PINNING. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 15241299 ↗
• MalfunctionOct 27, 2017Break

  IT WAS REPORTED THAT THE IMPLANT BROKE UPON INSERTION INTO THE PROXIMAL PHALANX. SITE WAS TAPPED BEFORE INSERTION INTO VERY HARD BONE. THE BROKEN IMPLANT WAS DRILLED OUT & RETAPPED WITH 2.7 TAP. A NEW IMPLANT WAS OPENED & COMPLETED THE CASE WITHOUT FURTHER ISSUE AND THERE WAS NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6984025 ↗