JuggerKnot CM-99145BRNRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00810020087215), received between Jan 11, 2023 and Aug 5, 2024 — classified as 13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Fracture; Fracture

  ACCORDING TO THE REPORTER, "THE TIP OF INSERTER WAS FRACTURED DURING USE, AND THE FRACTURED PIECE OF INSERTER HAS BEEN REMAINING IN THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912342 ↗
• MalfunctionMay 13, 2024Fracture; Fracture

  ACCORDING TO THE REPORTER: "IT WAS REPORTED THAT DURING THE SURGERY, TIP OF THE INSERTER WAS FRACTURED WHILE THE SURGEON TRIED TO IMPLANT THE ANCHOR INTO THE PATIENT'S BURR HOLE. FORTUNATELY, THE FRACTURED PIECE OF INSERTER COULD BE REMOVED, SO THERE IS NO REMAINS IN THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305124 ↗
• MalfunctionMay 13, 2024Fracture; Fracture

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE INSERTER OF THIS COMPLAINT PRODUCT COULDN'T BE PULLED OUT AFTER THE SURGEON INSERTED THE ANCHOR INTO THE PATIENT'S BURR HOLE. AND THE SURGEON PULLED THE INSERTER TO PULL IT OUT FROM THE PATIENT'S BURR HOLE, THEN TIP OF THE INSERTER WAS FRACTURED AND REMAINING IN THE PATIENT'S BURR HOLE. FORTUNATELY, THE FRACTURED PIECE OF INSERTER COULD BE REMOVED, SO THERE IS NO REMAINS IN THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19303199 ↗
• MalfunctionMar 15, 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 COULDN'T BE IMPLANTED. THEREFORE, THE SURGEON USED A BACK UP PRODUCT FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913284 ↗
• MalfunctionSep 6, 2023Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR OF THIS COMPLAINT PRODUCT COULDN'T BE IMPLANTED INTO THE PATIENT'S BURR HOLE, AND THE INSERTER OF IT WAS BENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691463 ↗
• MalfunctionMay 24, 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 PRODUCT FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16996797 ↗
• MalfunctionMay 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS PULLED OUT FROM THE BURR HOLE WHICH WAS MADE WITH A PUNCH. THEREFORE, THE SURGEON USED A COMPETITOR'S PRODUCT FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16996381 ↗
• MalfunctionMay 11, 2023Component Misassembled; Component Misassembled

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR HAD NOT BEEN SET ON THE PROPER POSITION WHEN THE NURSE OPENED THE PACKAGE. THE SURGEON TRIED TO USE THIS COMPLAINT PRODUCT FOR THE SURGERY, BUT HE COULDN'T INSERT THE ANCHOR INTO THE PATIENT'S BURR HOLE LIKE A NORMAL PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913737 ↗
• MalfunctionMay 2, 2023Positioning Problem; Positioning Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR OF THIS COMPLAINT PRODUCT COULDN'T BE INSERTED INTO THE PATIENT'S BURR HOLE. THE SURGEON USED THE PLURAL SAME PRODUCTS FOR THE SURGERY, BUT ONLY THIS COMPLAINT PRODUCT COULDN'T BE INSERTED INTO THE PATIENT'S BURR HOLE LIKE A NORMAL PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16855110 ↗
• MalfunctionApr 14, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, "IT WAS FOUND THAT THE SOMETHING HAS BE REMAINED IN THE PATIENT'S BODY WHEN THE SURGEON CHECKED THE X-RAY PHOTO OF THE PATIENT AFTER THE SURGERY. THE SURGEON CHECKED THE COMPLAINT PRODUCT, HE FOUND THAT THE TIP OF INSERTER OF THE COMPLAINT PRODUCT WAS FRACTURED. THIS INCIDENT DIDN'T BE NOTICED DURING THE SURGERY. THE SURGEON SAID THE SURGERY DATE IS UNDECIDED, BUT THE SURGERY OF REMOVING THE FRACTURED PIECE OF INSERTER IS PLANNED TO BE PERFORMED AFTER ABOUT A HALF YEAR TO A YEAR LATER".

  Patient problems: Foreign Body In Patient

  MAUDE report 16742881 ↗
• MalfunctionFeb 20, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, "IT WAS REPORTED DURING SURGERY, THE ANCHOR OF THIS COMPLAINT PRODUCT HAD NOT BE SET ON THE PROPER POSITION FROM THE PACKAGE WAS OPENED. IT WAS REPORTED THAT THE ANCHOR SEEMED TO CAME OFF FROM THE TIP OF THE INSERTER WHEN THE PACKAGE WAS OPENED. THE SURGEON TRIED TO USE THIS COMPLAINT PRODUCT FOR THE SURGERY, BUT THE ANCHOR COULD NOT BE IMPLANTED LIKE A NORMAL PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406085 ↗
• MalfunctionJan 11, 2023Break; Break

  ACCORDING TO THE REPORTER, "IT WAS REPORTED DURING SURGERY THE SURGERY, THE NEEDLE CAME OFF FROM THE SUTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142806 ↗
• MalfunctionJan 11, 2023Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE NEEDLE WAS BENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142405 ↗