Jet-X 71067323Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010607775), received between Aug 21, 2020 and Jun 9, 2022 — classified as 7 malfunctions.

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

• MalfunctionJun 9, 2022Break; Mechanics Altered; Break; Mechanics Altered

  IT WAS REPORTED THAT THE SIDE OF TIGHTENING OF THE 8MM RATCHET WRENCH IS BROKEN, IT DOESN´T TIGHTEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644846 ↗
• MalfunctionMar 20, 2022Break; Break

  IT WAS REPORTED THAT, AN 8MM RATCHET WRENCH WAS BREAKING AND NOT WORKING PROPERLY AND NEEDS TO BE REPLACED. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831434 ↗
• MalfunctionMay 19, 2021Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT, THE 8MM RATCHET WRENCH WAS FOUND TO NOT BE RATCHETING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850202 ↗
• MalfunctionApr 23, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, BOTH OF THE 8MM RATCHET WRENCH DO NOT RATCHET. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716297 ↗
• MalfunctionApr 23, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, BOTH OF THE 8MM RATCHET WRENCH DO NOT RATCHET. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716291 ↗
• MalfunctionSep 28, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE 8MM RATCHET WRENCH WAS NOT HOLDING ITS RATCHET ANYMORE. THIS HAPPENED DURING USE OUTSIDE THE PATIENT. NO DELAY. S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 10597515 ↗
• MalfunctionAug 21, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING INSPECTION THE WRENCH WAS SEEN SPIN FREELY RATHER THAN RATCHET AS IT SHOULD. NO CASE RELATED THEREFORE NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10437547 ↗

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