JuggerKnot CM-99114BNRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00810020087116), received between Dec 9, 2022 and Jul 8, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE INSERTER OF THIS COMPLAINT PRODUCT WAS FRACTURED WHILE THE SURGEON TRIED TO IMPLANT THE ANCHOR INTO THE PATIENT'S BURR HOLE, AND THE FRACTURED PIECE OF INSERTER HAS BEEN REMAINED IN THE PATIENT'S BODY. BY THE WAY, THE SURGEON MADE AN ADDITIONAL BURR HOLE AND USED A BACK UP OF THE SAME PRODUCT FOR THE SURGERY AND FINISHED IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438219 ↗
• MalfunctionFeb 15, 2024Material Frayed; Material Twisted/Bent; Material Frayed; Material Twisted/Bent

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR COULDN'T BE IMPLANTED LIKE A NORMAL PRODUCT. AFTER THAT, THE SURGEON NOTICED THAT THE TIP OF INSERTER WAS BENT, AND THE ANCHOR WAS ABOUT TO BREAK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710817 ↗
• MalfunctionSep 8, 2023Fracture; Fracture

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF INSERTER WAS FRACTURED DURING USE. BUT, THE SURGEON DIDN'T NOTICE THAT THE FRACTURING OCCURRED ON THE TIP OF INSERTER DURING THE SURGERY. AFTER THE SURGERY, IT WAS FOUND THAT THE PIECE OF INSERTER WAS REMAINING IN THE PATIENT'S BONE BY X-RAY, AND IT WAS CONFIRMED THAT THE INSERTER OF THIS COMPLAINT PRODUCT HAD BEEN FRACTURED. SO, THE SURGEON REMOVED THE FRACTURED PIECE OF INSERTER FROM THE PATIENT'S BONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17716018 ↗
• MalfunctionSep 1, 2023Fracture; Fracture

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF INSERTER WAS FRACTURED WHILE THE SURGEON TRIED TO IMPLANT AN ANCHOR INTO THE PATIENT'S BURR HOLE. THIS INCIDENT OCCURRED ON THE 3 PRODUCTS, AND 1 OF 3 PRODUCTS WAS DISCARDED IN THE HOSPITAL. AND THE FRACTURED PIECE OF INSERTER OF THE 1 OF 3 COMPLAINT PRODUCTS IS "REMAINING" IN THE PATIENT'S BODY. AND IT WAS REPORTED AS WELL THAT THE SURGEON DIDN'T "USE" A GUIDE WHEN HE TRIED TO IMPLANT AN ANCHOR."

  Patient problems: Foreign Body In Patient

  MAUDE report 17674603 ↗
• MalfunctionSep 1, 2023Fracture; Fracture

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF INSERTER OF THIS COMPLAINT PRODUCT WAS FRACTURED. FORTUNATELY, IT HAS NOT BEEN REPORTED THAT THE FRACTURED PIECE OF INSERTER REMAINING IN THE PATIENT'S BODY UNTIL TODAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674583 ↗
• MalfunctionMay 11, 2023Component Misassembled; Component Misassembled

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR HAD ALREADY BEEN ABOUT TO COME OFF FROM THE TIP OF INSERTER BEFORE USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913875 ↗
• MalfunctionMay 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR OF THIS COMPLAINT PRODUCT WAS PULLED OUT UNINTENTIONALLY. THEREFORE, THE SURGEON USED A BACK UP OF THE SAME PRODUCT FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888613 ↗
• MalfunctionMay 2, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR OF THIS COMPLAINT PRODUCT PULLED OUT UNINTENDED ALTHOUGH THE SURGEON IMPLANTED IT FOLLOWING NORMAL USAGE, AND IT WAS CONFIRMED THAT THE TIP OF INSERTER WAS FRACTURED. THERE IS THE POSSIBILITY THAT THE FRACTURED PIECE OF INSERTER HAS BE REMAINED IN THE PATIENT'S BODY."

  Patient problems: Foreign Body In Patient

  MAUDE report 16857520 ↗
• MalfunctionMay 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR OF THIS COMPLAINT PRODUCT PULLED OUT UNINTENDED ALTHOUGH THE SURGEON IMPLANTED IT FOLLOWING NORMAL USAGE. THE SURGERY WAS FINISHED WITH A BACK UP PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846861 ↗
• MalfunctionDec 9, 2022Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE INSERTER COULDN'T BE PULLED OUT EASILY FROM THE PATIENT'S BURRHOLE AFTER THE SURGEON INSERTED THE ANCHOR. FINALLY, HE COULD PULL OUT THE INSERTER FROM THE PATIENT'S BURR HOLE, BUT IT WAS FOUND THAT THE TIP OF INSERTER WAS FRACTURED. HE PULLED OUT THE ANCHOR FROM THE PATIENT'S BURR HOLE TO TRY TO REMOVE THE FRACTURED PIECE OF INSERTER, BUT IT COULDN'T BE DONE. SO, HE DECIDED TO FINISH THE SURGERY WITHOUT REMOVING THE FRACTURED PIECE OF INSERTER FROM THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954786 ↗