ILIZAROV SYSTEMS 71070367Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556119174), received between Aug 25, 2020 and Jun 22, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN EXTERNAL FIXATION, A RATCHET WRENCH HAD FAILED TO FUNCTION PROPERLY BECAUSE IT SIZED UP. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038904 ↗
• MalfunctionMay 26, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN EXTERNAL FIXATION SURGERY, THE HANDLE OF A RATCHET WRENCH WAS JAMMING. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887428 ↗
• MalfunctionMay 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, A RATCHET WRENCH WAS SEEN TO STICK, A UNIVERSAL CHUCK DID NOT TIGHTEN PROPERLY, A TUBULAR ANGULATED WRENCH WAS RUSTY, A DRILL TISSUE PROTECTOR - LONG AND A DEPTH GAUGE SHORT WERE BENT. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806390 ↗
• MalfunctionMay 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, THE GREY/GOLD DRIVER OF A RATCHET WRENCH WAS FROZEN. AS THIS WAS NOTICED AFTER A TRAUMA SURGERY DURING A POST-OPERATIVE INSPECTION OF INSTRUMENTS IN THE STERILE PROCESSING DEPARTMENT., NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781358 ↗
• MalfunctionMar 29, 2021Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE SHORT IS BROKEN AND THE RATCHET WRENCH IS BROKEN AND STRIPPED. UNKNOWN WHEN THIS HAPPENED OR IF THERE IS A PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586742 ↗
• MalfunctionDec 31, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING USE OUTSIDE THE PATIENT THE GOLD END OF THE RATCHET WRENCH DID NOT RATCHET. THERE WAS NO DELAY AND NO BACK UP APPLICABLE FOR THIS EVENT. NO INJURIES REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11099910 ↗
• MalfunctionDec 31, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING USE OUTSIDE THE PATIENT THE GOLD END OF THE RATCHET WRENCH DID NOT RATCHET. THERE WAS NO DELAY AND NO BACK UP APPLICABLE FOR THIS EVENT. NO INJURIES REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11099908 ↗
• MalfunctionOct 20, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING EFIP INSPECTION THE RATCHET WRENCH WAS FOUND NOT TORQUING. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10707767 ↗
• MalfunctionSep 10, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE RATCHET WRENCH FROZE UP AND WAS NO LONGER WORKS. THE ISSUE HAPPENED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW TO FINISH THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10517618 ↗
• MalfunctionSep 8, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE WRENCH WAS STICKING AND NOT WORKING PROPERLY DURING THE EXTERNAL FIXATION CASE. THE PROCEDURE WAS COMPLETED USING AN SMITH&NEPHEW BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10503222 ↗
• MalfunctionAug 25, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, THROUGH REPEATED USE, THE WRATCH SYSTEM HAS BEGUN TO GET STUCK. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10448877 ↗

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