JuggerKnot Soft Anchors 912076Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00880304520820), received between Sep 16, 2019 and Dec 3, 2025 — classified as 3 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705375 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS NOTICED THAT THE TIP OF THE INSERTER HAS BEEN FRACTURED. THEREFORE, THE SURGEON DIDN'T USE THIS COMPLAINT PRODUCT FOR THE SURGERY. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594106 ↗
• MalfunctionNov 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SUTURING PROCEDURE, THE INSERTER TIP FRACTURED DURING IMPLANTATION OF THE ANCHOR INTO THE PATIENT'S BURR HOLE. THE TIP OF THIS PRODUCT WAS SUCCESSFULLY RECOVERED FROM THE PATIENT, AND AN ALTERNATE PRODUCT WAS USED TO COMPLETE THE SURGERY. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550256 ↗
• MalfunctionNov 4, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464196 ↗
• MalfunctionJul 23, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576593 ↗
• MalfunctionJun 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY THAT IT WAS OBSERVED THAT THE PRODUCT WAS FRACTURED WHEN THE PACKAGE WAS OPENED. THERE WAS NO HARM, INJURY, SURGICAL/MEDICAL INTERVENTION TO PATIENT AND NO REPORT OF A DELAY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132957 ↗
• MalfunctionFeb 3, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY THAT THE TIP OF THE INSERTER WAS ALREADY BENT WHEN THE NURSE OPENED THE PACKAGE. THERE WAS NO HARM, INJURY, SURGICAL/MEDICAL INTERVENTION TO PATIENT AND NO RECORD OF A DELAY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293297 ↗
• MalfunctionNov 27, 2024Mechanical Jam; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795796 ↗
• MalfunctionSep 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NITINOL TIP OF THE ANCHOR BENT DURING INSERTION AND COULD NOT BE USED. SECOND IMPLANT WAS OPENED AND USED SUCCESSFULLY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134766 ↗
• MalfunctionJun 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS ATTEMPTING TO INSERT THE IMPLANT INTO THE PATIENT'S BONE THE IMPLANT FRACTURED. A SECOND IMPLANT WAS USED WITHOUT ANY PROBLEMS. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478698 ↗
• MalfunctionFeb 22, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSERTER NEEDLE OF THE DEVICE WAS BENT AND BROKEN IN HALF DURING A PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763297 ↗
• MalfunctionJun 27, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210749 ↗
• MalfunctionJun 27, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210744 ↗
• MalfunctionJun 12, 2023Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE THE SURGEON ATTEMPTED TO USE THE DEVICE THE PLASTIC SLEEVE ON THE SHAFT BECAME JAMMED AND WOULD NOT SLIDE, NOT ALLOWING THE IMPLANT TO BE DEPLOYED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107193 ↗
• MalfunctionFeb 9, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE ANCHOR WAS SLIGHTLY BENT. DOCTOR ATTEMPT TO STRAIGHTEN IT WITH A NEEDLE DRIVER BUT IMPLANT DIDN'T WORK PROPERLY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16337139 ↗
• MalfunctionJan 10, 2023Fracture; Premature Separation; Fracture; Premature Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132043 ↗
• MalfunctionDec 1, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PLASTIC SLIDING STABILIZING SLEEVE WAS JAMMED AND UNABLE TO BE MOVED SO IMPLANT WAS NOT ATTEMPTED TO BE IMPLANTED. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893678 ↗
• InjuryNov 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF INSERTER FRACTURED. AFTER THE SURGERY WAS FINISHED, THE FRACTURED PIECE OF INSERTER REMAINED IN THE PATIENT'S BODY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15760031 ↗
• MalfunctionOct 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ANCHOR WAS DRIVEN IN, BUT THE SUTURE BROKE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543131 ↗
• MalfunctionApr 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE INSERTER FRACTURED WHILE THE SURGEON TRIED TO INSERT THE ANCHOR INTO THE PATIENT'S BURR HOLE. SUBSEQUENTLY, THE SURGEON WAS ABLE TO REMOVE THE FRACTURED PIECE, SO NO HARM WAS EXPERIENCED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084583 ↗
• MalfunctionFeb 15, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538642 ↗
• MalfunctionFeb 1, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SLEEVE DID NOT MOVE ON THE INSTRUMENT AS INTENDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415709 ↗
• MalfunctionJan 25, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE SURGERY, THE CLEAR SLEEVE OF THE JUGGERKNOT DID NOT SLIDE AS USUAL. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342064 ↗
• MalfunctionJan 14, 2022Failure to Fire; Material Twisted/Bent; Mechanical Jam; Failure to Fire; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT THE ANCHOR CAME OUT OF THE BOX AND THE PLASTIC SLEEVE WAS SLID HALFWAY DOWN THE SHAFT. IT WOULD MOVE UPWARDS BUT WAS VERY DIFFICULT AND HARD TO SLIDE. IT WAS NOT ABLE TO BE SLID DOWNWARDS TO ITS NORMAL START POSITION CLOSER TO THE TIP. DEPLOYMENT WAS ATTEMPTED BUT THE SHAFT BENT AND THE ANCHOR WAS NOT IMPLANTED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257706 ↗
• MalfunctionJan 14, 2022Device Dislodged or Dislocated; Mechanical Jam; Device Dislodged or Dislocated; Mechanical Jam

  IT WAS REPORTED THAT THE SLIDING PLASTIC SLEEVE ON INSERTER SHAFT BECAME JAMMED HALFWAY DURING DEPLOYMENT. THE ANCHOR WAS DEPLOYED BUT NOT AT THE CORRECT DEPTH SO IT WAS PULLED OUT. THE ANCHOR WAS NOT IMPLANTED IN THE PATIENT AND WAS DISCARDED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257695 ↗