SR PIP 17-1325Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886385019840), received between Sep 4, 2019 and Oct 13, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 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.

• MalfunctionOct 13, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE SIZE 1 PROXIMAL BROACH TIP BROKE OFF IN THE PATIENTS PHALANGE WHILE THE SURGEON WAS TRYING TO REMOVE THE BROACH. SEQUENTIAL BROACHING (UP TO SIZE 2) WAS COMPLETED. THE TIP REMAINED IN THE PATIENT AS REMOVAL WOULD HAVE BEEN SIGNIFICANTLY MORE INVASIVE." THERE WAS A 5 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15593974 ↗
• MalfunctionSep 4, 2019Naturally Worn

  UPON INCOMING INSPECTION, ITEMS WERE VISIBLY WORN. NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962910 ↗
• MalfunctionSep 4, 2019Naturally Worn

  UPON INCOMING INSPECTION, ITEMS WERE VISIBLY WORN. NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962909 ↗