JuggerKnot CM-99115Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810020087147), received between Aug 25, 2022 and Feb 4, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Integrity Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT SOMETHING LIKE A PIECE OF WIRE IS REMAINING INSIDE OF THE PATIENT'S BODY BY X-RAY AFTER THE SURGERY(PLEASE REFER TO AN ATTACHED PHOTO FOR DETAILS). THE SURGEON AND THE NURSE COULDN'T BE IDENTIFY WHAT THE OBJECT IS. AND ALL OF THE PRODUCT'S WHICH WERE USED FOR THE SURGERY DISCARDED IN THE HOSPITAL. NOW, THERE IS NO PLANS FOR REOPERATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259297 ↗
• MalfunctionSep 11, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF INSERTER OF THIS COMPLAINT PRODUCT'S DEVICE WAS FRACTURED DURING USE. THE SURGERY WAS FINISHED WITHOUT REMOVING THE FRACTURED PIECE OF INSERTER FROM THE PATIENT'S BODY, AND IT WAS CONFIRMED THAT THE FRACTURED PIECE OF INSERTER HAS BEEN REMAINED IN THE PATIENT'S BODY BY X-RAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027138 ↗
• MalfunctionMar 6, 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 WAS PULLED OUT UNINTENTIONALLY. THEREFORE, THE SURGEON MADE AN ADDITIONAL BURR HOLE AND USED A BACK UP PRODUCT FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845783 ↗
• MalfunctionNov 8, 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 WAS PULLED OUT FROM THE PATIENT'S BURR HOLE UNINTENTIONALLY. THEREFORE, THE SURGEON USED A BACK UP PRODUCT FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095596 ↗
• MalfunctionSep 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER: "IT WAS REPORTED THAT DURING THE ARTHROSCOPIC BANKART REPAIR SURGERY, THE ANCHOR OF THE COMPLAINT WAS PULLED OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465823 ↗
• MalfunctionAug 25, 2022Break; Break

  ACCORDING TO REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE INSERTER WAS FRACTURED DURING USE. THE SURGEON CONSIDERED REMOVING THE FRACTURED PIECE OF INSERTER, OR NOT DURING THE SURGERY. BUT, HE DECIDED TO FINISH THE SURGERY WITHOUT THE FRACTURED PIECE OF INSERTER FROM THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294691 ↗