NA 04.130.152SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982112545), received between Aug 2, 2022 and Aug 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionAug 2, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF SURGERY FOR A FINGER FRACTURE. THE SURGEON MADE THE CUT OF THE HEAD PART OF THE PLATE BASED ON THE UNDERSTANDING THAT A PLATE SHOULD BE CUT AT THE CUT-LINE ON THE CUTT-PLIERS, BUT THE PLATE PART IN THE LONG AXIS DIRECTION OF THE CUTT-PLIERS WAS ALSO CUT. THEREFORE, THE SURGEON GAVE UP USING THE PLATE AND USED ANOTHER PLATE (Y-TYPE PLATE) FOR PROCEDURE. TO CUT THE HEAD PART OF THE Y-TYPE PLATE, THE SURGEON USED A HOSPITAL OWNED PIN CUTTER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A 1.3MM TI LCKNG T-PLATE 3H HEAD/5H SHAFT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15148615 ↗