Jet-X 71067322Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010607768), received between Feb 28, 2021 and Feb 17, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A JET-X 10MM RATCHET WRENCH WAS OBSERVED TO BE BROKEN AND TO NO LONGER WORK DUE TO WEAR AND TEAR. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549229 ↗
• MalfunctionJun 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A 10MM RATCHET WRENCH WON'T RATCHET. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918388 ↗
• MalfunctionMay 19, 2021Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT DURING STERILIZATION PROCESS, IT WAS NOTICED THAT THE 10MM RATCHET WRENCH SIDE WOULD NOT RATCHET. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850308 ↗
• MalfunctionApr 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, IT WAS FOUND THAT THE RATCHET HAS BURRS AND NEEDS TO BE REPLACED. INSTRUMENTS WERE OUTSIDE THE PATIENT. THERE WAS NO DELAY AND PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646843 ↗
• MalfunctionFeb 28, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP INSPECTION PROCESS WAS IDENTIFIED THAT A GEAR OF THE 10MM RATCHET WRENCH WAS BROKEN. WHEN TIGHTENING THE GOLD SIDE DID SKIP A GEAR TOOTH INSIDE THE RATCHETING MECHANISM. THERE WAS NO PATIENT INVOLVED WHEN THIS ISSUE WAS NOTICED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11390985 ↗

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