RENOVATION 71367566Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010407191), received between Sep 30, 2020 and Nov 17, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE TIP OF THE CARBIDE PUNCH BROKE OFF WHILE BEING USED OUTSIDE THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A SIMILAR S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566668 ↗
• MalfunctionMar 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING USE, THE INSTRUMENTS BENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED. UPON INVESTIGATION, IT WAS FOUND THAT THE CARBIDE PUNCH HAS A BROKEN TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492916 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) CARBIDE PUNCH FRACTURED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383584 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A CARBIDE PUNCH BROKE OFF. NO PIECES FELL INTO THE PATIENT. NO SURGICAL DELAY OCCURRED AS A CONSEQUENCE OF THIS ISSUE, AND THE PROCEDURE WAS CONCLUDED WITH A BACKUP DEVICE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245405 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE CARBIDE PUNCH BROKE. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED, OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281901 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, A CARBIDE PUNCH BROKE. SURGERY WAS COMPLETED WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546064 ↗
• MalfunctionSep 30, 2020Break; Break

  IT WAS REPORTED THAT DURING SET UP AND INSPECTION, THE CARBIDE PUNCH WAS FOUND TO BE BROKEN AT THE TIP; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10610285 ↗