NA 400.806Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982203618), received between Dec 11, 2019 and Dec 11, 2019 — classified as 1 malfunction.

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

• MalfunctionDec 11, 2019Naturally Worn; Naturally Worn

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 1, THE COMPACT HAND 1.5 SYSTEM WAS USED WITH THE PATIENT FOR A BROKEN FINGER; THE SCREWDRIVER ROLLED THE SCREW HEAD SEVERAL TIMES. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVERS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9448981 ↗