CHS 110054Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010033499), received between Dec 4, 2020 and Dec 19, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION PROCEDURE, WHEN INSERTING THE LAG SCREW WITH THE CLASSIC INSERTION WRENCH DEVICE, THE TIP OF THE DEVICE SNAPPED LOOSE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO PIECES WERE LEFT INSIDE OF THE PATIENT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357505 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT THE END OF RETAINING ROD OF THE CLASSIC INSERTION WRENCH WAS BROKEN OFF. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611785 ↗
• InjuryJan 6, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE END OF A CLASSIC INSERTION WRENCH CRACKED WHILE IT WAS INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY AS CONSEQUENCE OF THIS PROBLEM. NEVERTHELESS, PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176993 ↗
• MalfunctionNov 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR AN INTERNAL FIXATION SURGERY, A CLASSIC INSERTION WRENCH WAS FOUND BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833421 ↗
• MalfunctionMay 20, 2021Naturally Worn; Physical Resistance/Sticking; Naturally Worn; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PERC DIRECT MEASURING GAUGE AND THE CLASSIC INSERTION WRENCH NEED REPLACING DUE TO WEAR. THE PERC DIRECT MEASURING GAUGE MARKINGS ARE NO LONGER LEGIBLE AND THE CLASSIC INSERTION WRENCH IS GETTING HUNG UP IN THE CHS CLASSIC PLATES. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853740 ↗
• MalfunctionDec 4, 2020Break; Break

  IT WAS REPORTED DURING THE PROCEDURE THAT THE DEVICE WAS BROKEN OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944942 ↗

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