JuggerKnot CM-99529BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810020087338), received between Dec 21, 2022 and Mar 21, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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.

• MalfunctionMar 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR OF THIS COMPLAINT PRODUCT DIDN'T BE IMPLANTED INTO THE PATIENT'S BURR HOLE. THEREFORE, THE SURGEON USED AND IMPLANTED A BACK UP OF THE SAME PRODUCT INTO THE SAME BURR HOLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949238 ↗
• MalfunctionAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS PULLED OUT FROM THE PATIENT'S BURR HOLE. THEREFORE, THE SURGEON MADE ANOTHER BURR HOLE AND IMPLANTED A BACK UP OF THE SAME PRODUCT'S ANCHOR INTO IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502624 ↗
• MalfunctionJun 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS PULLED OUT FROM THE PATIENT'S BURR HOLE UNINTENTIONALLY.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159576 ↗
• MalfunctionMay 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS PULLED OUT UNINTENTIONALLY ALTHOUGH THE SURGEON IMPLANTED IT FOLLOWING THE NORMAL USAGE. THEREFORE, THE SURGEON USED A BACK UP ANOTHER PRODUCT FOR THE SURGERY.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960683 ↗
• MalfunctionMar 22, 2023Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR DIDN'T BECOME TO THE SPHERICAL FORM, SO ANCHOR PULLED OUT FROM THE PATIENT'S BURR HOLE. THEREFORE, THE SURGEON USED A BACK UP PRODUCT FOR THE SURGERY.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594763 ↗
• MalfunctionDec 21, 2022Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, "WHEN INSERTING THE JUGGERKNOT BB TRIPLE LOADED, THE ANCHOR JAMMED INSIDE THE SETTING SLEEVE. AFTER REGULAR PREDRILLING AND INSERTION OF THE JUGGERKNOT ANCHOR, AN ATTEMPT WAS MADE TO PULL THE INSERTER OF THE ANCHOR OUT OF THE SETTING SLEEVE. DUE TO THE SMALLER INNER LUMEN OF THE SETTING SLEEVE AND THE MANY THREADS, THIS WAS NOT POSSIBLE. THE USER HAD TO HIT THE SETTING SLEEVE WITH A HAMMER TO RELEASE THE INSERTER AND THE SETTING SLEEVE. THE SOFT ANCHOR BROKE OUT WITH ONE ANCHOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16029463 ↗
• MalfunctionDec 21, 2022Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, "WHEN INSERTING THE JUGGERKNOT BB TRIPLE LOADED, THE ANCHOR JAMMED INSIDE THE SETTING SLEEVE. AFTER REGULAR PREDRILLING AND INSERTION OF THE JUGGERKNOT ANCHOR, AN ATTEMPT WAS MADE TO PULL THE INSERTER OUT OF THE SETTING SLEEVE. DUE TO THE SMALL INNER LUMEN OF THE SETTING SLEEVE AND THE MANY THREADS, THIS WAS NOT EASILY POSSIBLE. THE USER HAD TO IT THE SETTING SLEEVE WITH A HAMMER TO RELEASE THE INSERTER AND THE SETTING SLEEVE. THE SOFT ANCHOR BROKE OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16029362 ↗