RENOVATION 71369300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010406415), received between Aug 20, 2020 and Mar 20, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE RONGEUR 300MM W/ TEETH BROKE. ALL PIECES WERE RETRIEVED. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647420 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF THE RONGEUR 300MM W/TEETH HAD BROKEN OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935044 ↗
• InjuryMar 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE RONGEUR 300MM W/TEETH SNAPPED DURING CEMENT REMOVAL. THE BROKEN PIECE WAS RETRIEVED. SURGERY WAS RESUMED, WITH A SMITH AND NEPHEW BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720905 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT A POLARSTEM STEM INSERTER WAS NOTICED TO BE DEFECTIVE AND A RENOVATION RONGEUR 300MM WITH TEETH SHOWED A BROKEN TIP. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNSPECIFIED. THEREFORE, PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 13286884 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT A CEMENT DRILL 4.5MM ((B)(4)) BROKE INSIDE THE PATIENT, A RONGEUR 300MM WITH TEETH ((B)(4)) AND A RONGEUR 200MM WITH TEETH ((B)(4)) ARE BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002290 ↗
• MalfunctionJun 2, 2021Break; Failure to Align; Break; Failure to Align

  IT WAS REPORTED THAT TWO RONGEUR 300MM W/TEETH WERE MISALIGNED AND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918402 ↗
• MalfunctionJun 2, 2021Break; Failure to Align; Break; Failure to Align

  IT WAS REPORTED THAT TWO RONGEUR 300MM W/TEETH WERE MISALIGNED AND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918397 ↗
• InjuryAug 20, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2020 THE RONGEUR 300MM W/TEETH BROKE OFF WHILE BEING USED IN PATIENT. TIP WAS REMOVED AND BELIEVED IN ITS ENTIRETY. AN X-RAY WAS TAKEN TO CONFIRM THAT NO PIECE WAS LEFT INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS CONCLUDED OR IF THERE WAS A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10434665 ↗