RENOVATION 71369006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010437624), received between Sep 30, 2020 and Jan 13, 2026 — classified as 1 injury, 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Fracture

  IT WAS REPORTED THAT, DURING A ATQ REVIEW SURGERY, THE SURGEON REQUESTED THE DRILL BIT TO DEEPEN THE FEMORAL CANAL, AND DURING THE DRILLING ONE (1) CEMENT DRILL 6MM BROKE INSIDE THE PATIENT'S FEMUR. THE SURGEON TRIED FOR A LONG TIME TO REMOVE THE REMAINING PIECE OF THE DRILL BIT BUT WAS UNSUCCESSFUL, AND DECIDED TO PROCEED, LEAVING THE BROKEN TIP OF THE DRILL BIT IN THE FEMORAL CANAL. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24052182 ↗
• MalfunctionSep 30, 2020Break; Break

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT, THE CEMENT DRILL 6MM BROKE. NO DELAY OR HARM TO THE PATIENT REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10611047 ↗

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