JuggerKnot Soft Anchors 110005315Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00880304568204), received between Apr 9, 2021 and Sep 10, 2026 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

3 other recalls cover devices cleared under the same FDA submission (K110145, K150768, K973775); they may or may not involve this specific model.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Fracture

  It was reported that three sutures were used; one of them penetrated forcefully and deeply. Upon attempting to secure it, the anchor portion was found to be torn. Suturing was successfully completed using a new spare suture. No harm was caused to the patient. It was reported that no further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715972 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Impaired Healing

  MAUDE report 25170507 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION OF THE JUGGERKNOT ON AN UNKNOWN DATE APPROXIMATELY THREE (3) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WENT TO THE WOUND CLINIC WHERE IT WAS NOTED THE THREAD WAS ABLE TO BE SEEN. THE PATIENT UNDERWENT WASHOUT OF THE WOUND AND REMOVAL OF TISSUE APPROXIMATELY ONE (1) MONTH POST-IMPLANTATION. THE SUTURE REMAINS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Impaired Healing

  MAUDE report 25170436 ↗
• InjuryJan 11, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18494897 ↗
• InjuryOct 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS PULLING ON THE SUTURES OF THE IMPLANT THE SUTURES FRACTURED. THE ANCHOR REMAINED IMPLANTED IN THE PATIENT. THE SURGEON USED THREE ADDITIONAL IMPLANT AND THE SUTURES FRACTURED ON ALL THREE AND THE ANCHORS REMAINED IMPLANTED IN THE PATIENT. THERE WAS NO HARM REPORTED TO THE PATIENT OR PLAN TO EXPLANT THE ANCHORS FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17967321 ↗
• InjuryOct 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS PULLING ON THE SUTURES OF THE IMPLANT THE SUTURES FRACTURED. THE ANCHOR REMAINED IMPLANTED IN THE PATIENT. THE SURGEON USED THREE ADDITIONAL IMPLANT AND THE SUTURES FRACTURED ON ALL THREE AND THE ANCHORS REMAINED IMPLANTED IN THE PATIENT. THERE WAS NO HARM REPORTED TO THE PATIENT OR PLAN TO EXPLANT THE ANCHORS FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17967319 ↗
• InjuryJun 13, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17117410 ↗
• MalfunctionJun 5, 2023Unsealed Device Packaging; Unsealed Device Packaging

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058465 ↗
• MalfunctionAug 11, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON COULDN'T IMPLANT THE ANCHOR AS INTENDED BECAUSE THE INSERTER OF THE DEVICE WAS BENT. THE SURGEON WAS NOT ABLE TO USE THIS PRODUCT PRODUCT FOR THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214161 ↗
• MalfunctionJun 13, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SURGERY, THE INSERTER OF THIS COMPLAINT PRODUCT WAS BENT WHEN THE SURGEON TRIED TO INSERT THE ANCHOR INTO THE PATIENT'S BURR HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681643 ↗
• MalfunctionJun 29, 2021Failure to Fire; Failure to Fire

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083445 ↗
• MalfunctionJun 29, 2021Firing Problem; Firing Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083444 ↗
• MalfunctionJun 29, 2021Firing Problem; Firing Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083443 ↗
• MalfunctionApr 9, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11640810 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110145, K150768, K973775. One submission often covers many models, so check the product and lot details in each record.

• Z-3252-2018 · Aug 3, 2018 · Terminated
  Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ank
• Z-1828-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
• Z-3109-2011 · Jul 21, 2011 · Terminated
  REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. Product Usage: The JuggerKnot Soft Anchors include various size ranges, each