NA 71070345Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556119341), received between Feb 10, 2020 and Feb 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K093047); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 10, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THE STEP DRILL BROKE, FINALLY, AN SMITH AND NEPHEW SAME SIZE DRILL WAS USED TO COMPLETE THE SURGERY. IT IS NOT KNOWN IF THE ITEM BROKE INSIDE OF THE PATIENT'S WOUND. NO INJURIES OR DELAYS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9690371 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434