JuggerKnot CM-99115BRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00810020087154), received between Jun 16, 2022 and Jan 30, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Fracture; Fracture

  ACCORDING TO THE REPORTER, "THE TIP OF THE 1 PRODUCT'S INSERTER(LOT: 23120524) WAS FRACTURED, AND THE FRACTURED PIECE OF INSERTER REMAINS IN THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277512 ↗
• MalfunctionDec 4, 2024Fracture; Fracture

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE COMPLAINT PRODUCT'S INSERTER WAS FRACTURED WHILE THE SURGEON TRIED TO INSERT THE ANCHOR INTO THE PATIENT' BURR HOLE, AND THE FRACTURED PIECE OF INSERTER HAS BEEN REMAINED IN THE PATIENT'S BODY. AND THE ANCHOR COULDN'T BE IMPLANTED. THE ABOVE SAME INCIDENT OCCURRED ON THE 2 SAME PRODUCTS. THEREFORE, THE SURGEON USED A BACK UP ANOTHER PRODUCT FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847459 ↗
• MalfunctionDec 4, 2024Fracture; Fracture

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE COMPLAINT PRODUCT'S INSERTER WAS FRACTURED WHILE THE SURGEON TRIED TO INSERT THE ANCHOR INTO THE PATIENT BURR HOLE, AND THE FRACTURED PIECE OF INSERTER HAS BEEN REMAINED IN THE PATIENT'S BODY. AND THE ANCHOR COULDN'T BE IMPLANTED. THE ABOVE SAME INCIDENT OCCURRED ON THE 2 SAME PRODUCTS. THEREFORE, THE SURGEON USED A BACK UP ANOTHER PRODUCT FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846833 ↗
• MalfunctionNov 26, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789711 ↗
• MalfunctionNov 26, 2024Fracture; Fracture

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE COMPLAINT PRODUCT'S INSERTER WAS FRACTURED DURING USE, AND THE ANCHOR COULDN'T BE IMPLANTED. SO, THE SURGEON MADE ANOTHER BURR HOLE AND IMPLANTED A BACK UP OF THE SAME PRODUCT'S ANCHOR INTO IT. THE SURGERY WAS FINISHED WITHOUT REMOVING THE FRACTURED PIECE OF INSERTER, SO IT HAS BEEN REMAINED IN THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788820 ↗
• MalfunctionNov 11, 2024Fracture; Fracture

  ACCORDING TO THE REPORTER, "THE TIP OF INSERTER WAS FRACTURED DURING USE AND THE SURGEON DECIDED TO FINISHED THE SURGERY WITHOUT REMOVING THE FRACTURED PIECE OF INSERTER FROM THE PATIENT'S BODY, SO IT HAS BE REMAINED IN THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658849 ↗
• MalfunctionFeb 23, 2024Fracture; Fracture

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE INSERTER WAS FRACTURED WHILE THE SURGEON TRIED TO IMPLANTED THE ANCHOR. AND THE SURGERY WAS FINISHED WITH THE FRACTURED PIECE OF INSERTER REMAINING IN THE PATIENT'S BODY."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766876 ↗
• MalfunctionApr 25, 2023Mechanical Problem; Mechanical 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 ALTHOUGH THE SURGEON IMPLANTED IT FOLLOWING THE NORMAL USAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16810284 ↗
• MalfunctionMar 22, 2023Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR PULLED OUT FROM THE PATIENT'S BURRHOLE ALTHOUGH THE SURGEON IMPLANTED THE ANCHOR OF THIS COMPLAINT PRODUCT FOLLOWING THE NORMAL USAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594811 ↗
• MalfunctionNov 30, 2022Ejection Problem; Ejection Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS PULLED OUT FROM THE PATIENT'S BURR HOLE WHEN THE SURGEON APPLIED TENSION TO THE SUTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888097 ↗
• MalfunctionNov 30, 2022Ejection Problem; Ejection Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR PULLED OUT FROM THE PATIENT'S BURR HOLE WHEN THE SURGEON APPLIED TENSION TO THE SUTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888047 ↗
• MalfunctionJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "JUGGERKNOT WITH BROADBAND TAPE FAILED, PULLED OUT OF BONE WHILE TIEING KNOTS FOR SLAP REPAIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14718561 ↗
• MalfunctionJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "JUGGERKNOT WITH BROADBAND TAPE FAILED, PULLED OUT OF BONE WHILE "TIEING" KNOTS FOR SLAP REPAIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14718554 ↗
• MalfunctionJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "JUGGERKNOT WITH BROADBAND TAPE FAILED, PULLED OUT OF BONE WHILE TIEING KNOTS FOR SLAP REPAIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14718518 ↗
• MalfunctionJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "JUGGERKNOT WITH BROADBAND TAPE FAILED, PULLED OUT OF BONE WHILE TIEING KNOTS FOR SLAP REPAIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14718510 ↗
• MalfunctionJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "JUGGERKNOT WITH BROADBAND TAPE FAILED , PULLED OUT OF BONE WHILE TIEING KNOTS FOR SLAP REPAIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14718473 ↗
• MalfunctionJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "JUGGERKNOT WITH BROADBAND TAPE FAILED, PULLED OUT OF BONE WHILE TIEING KNOTS FOR SLAP REPAIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14718470 ↗
• MalfunctionJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "JUGGERKNOT WITH BROADBAND TAPE FAILED, PULLED OUT OF BONE WHILE TIEING KNOTS FOR SLAP REPAIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14718412 ↗