HOFFMANN 4940-1-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327089158), received between Sep 30, 2019 and Sep 30, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 21, 2019Terminated

   Pin To Rod Coupling could not clamp the pin and rod as intended

   Z-0781-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionSep 30, 2019Loose or Intermittent Connection; Detachment of Device or Device Component; Loose or Intermittent Connection

  AS REPORTED: "DURING THE OPERATION, THE NEEDLE CLAMP OF HOFFMAN II PRODUCT [...] WAS NOT TIGHTLY CLAMPED. AFTER THE NAIL IS NAILED, WHEN CONNECTING THE PIN ROD CHUCK, IT IS FOUND THAT THE PIN CHUCK IS NOT CLAMPED TIGHTLY AND FALLS OFF AFTER SCREWING. SUBSEQUENTLY, THE OPERATION WAS PERFORMED BY OTHER BATCH PRODUCTS." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 15 MINUTES SURGICAL DELAY AND OTHER BATCH OF PRODUCT WAS USED TO COMPLETE THE SURGERY WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9137836 ↗