JUGGERKNOT SOFT ANCHORS 912068Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of JuggerKnot Soft Anchors (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet Juggerknot Soft Anchor is a small non-absorbable anchor used to fasten soft tissue to bone during orthopedic surgery. The 53 reports mostly describe the anchor or its inserter breaking, bending or twisting during placement, so the anchor would not hold, and in some cases a fragment was left behind in the patient. Reports describe 12 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00880304509641), received between Jan 14, 2020 and Aug 27, 2026 — classified as 12 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Fracture” (41 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.
Reports received per month
Most reported problems
Device problems
- Fracture41
- Material Twisted/Bent11
- Expulsion7
- Positioning Failure3
- Break1
- Component Missing1
- Detachment of Device or Device Component1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Foreign Body In Patient16
- Device Embedded In Tissue or Plaque1
- No Information1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Fracture
It was reported that during a procedure suture was damaged/broken, and it also became separated from the guide. A new implant was used.Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478494 ↗InjuryJun 8, 2026Fracture
IT WAS REPORTED THAT THE TIP OF AN INSERTER FRACTURED DURING OPEN REDUCTION AND INTERNAL FIXATION SURGERY. SINCE THE PRESERVED TIP WAS ONLY A FEW MILLIMETERS THICK, THE SURGERY WAS COMPLETED WHILE IT REMAINED INTACT. FOLLOWING COMPLETION OF THE PROCEDURE, POSTOPERATIVE RADIOGRAPHS WERE REVIEWED; THE FRAGMENT WAS NOT VISUALIZED, AND THE REPORTER INDICATED IT WAS LIKELY RETAINED WITHIN THE PATIENT. THE PATIENT HAS EXPERIENCED NO KNOWN IMPACTS OR CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 25428937 ↗MalfunctionMay 22, 2026Material Twisted/Bent
IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE COMPLAINT PRODUCT'S INSERTER WAS BENT WHILE THE SURGEON TRIED TO INSERT THE ANCHOR INTO THE PATIENT'S BURR HOLE, AND THE ANCHOR COULDN'T BE FIXED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25254871 ↗MalfunctionMay 21, 2026Fracture
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'S BURR HOLE, AND THE ANCHOR COULDN'T BE FIXED. FORTUNATELY, THE DEVICE WAS NOT RETAINED IN THE PATIENT'S BODY. 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 25242741 ↗MalfunctionMay 5, 2026Fracture
IT WAS REPORTED THAT A GUIDE TOOTH BROKE, WHICH PREVENTED PLACEMENT OF THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082756 ↗MalfunctionJan 6, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973482 ↗MalfunctionDec 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 23719518 ↗MalfunctionOct 30, 2025Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425419 ↗MalfunctionSep 11, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPLANTING THE ANCHOR THE IMPLANT FRACTURED. THERE WAS NO REPORT OF FOREIGN BODY RETAINED OR HARM TO THE PATIENT. ATTEMPT HAS 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 23033024 ↗MalfunctionMar 28, 2025Expulsion; Expulsion
IT WAS REPORTED THAT WHILE THE SURGEON WAS ATTEMPTING TO IMPLANT THE ANCHOR THERE WAS DAMAGE TO THE NEEDLE TIP AND THE SURGEON WAS NOT ABLE TO IMPLANT THE ANCHOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21718954 ↗MalfunctionMar 14, 2025Material Twisted/Bent; Material Twisted/Bent
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605442 ↗MalfunctionFeb 27, 2025Material Twisted/Bent; Material Twisted/Bent
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21478024 ↗InjuryAug 26, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THE SURGEON TRIED TO INSERT THE ANCHOR OF THIS COMPLAINT PRODUCT INTO THE PATIENT'S BURR HOLE; IT WAS HARD TO INSERT AND AS A RESULT, THE TIP OF INSERTER WAS FRACTURED AND THE FRACTURED PIECE OF INSERTER HAS REMAINED IN THE PATIENT'S BONE. THERE WAS NO REPORTED HARM OR INJURY TO PATIENT. AN APPROXIMATE 15 MINUTES DELAY WAS REPORTED BECAUSE THE ANCHOR WAS HARD TO INSERT INTO THE PATIENT'S BURR HOLE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 20064492 ↗MalfunctionJul 3, 2024Positioning Failure; Fracture; Material Twisted/Bent; Positioning Failure; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ELBOW COLLATERAL LIGAMENT SUTURING PROCEDURE, THE TIP OF TWO (2) SEPARATE INSERTERS BENT AND FRACTURED DURING IMPLANTATION OF THE ANCHOR INTO THE PATIENT'S BURR HOLE. THE SURGEON NOTED THAT THE DRILL POSITIONING MAY HAVE SHIFTED, RESULTING IN MISALIGNMENT AND EXCESSIVE STRESS LOAD. THE FRACTURED TIP FROM THIS PRODUCT WAS NOT RETAINED BY THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19671934 ↗InjuryJul 3, 2024Positioning Failure; Fracture; Material Twisted/Bent; Positioning Failure; Fracture; Material Twisted/Bent
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 19671931 ↗MalfunctionJun 24, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE SURGICAL NEEDLE OF THIS COMPLAINT PRODUCT WAS FRACTURED DURING USE. THEREFORE, THE SURGEON USED A BACK UP PRODUCT FOR THE SURGERY. NO FURTHER INFORMATION KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19594402 ↗MalfunctionJun 4, 2024Fracture; Expulsion; Fracture; Expulsion
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19461232 ↗MalfunctionJun 4, 2024Fracture; Expulsion; Fracture; Expulsion
IT WAS REPORTED THAT DURING A SOFT TISSUE FIXATION SURGERY, THE ANCHOR OF THE COMPLAINT PRODUCT WAS PULLED OUT UNINTENTIONALLY, AND THE TIP OF THE INSERTER WAS FRACTURED. THE SURGEON NOTICED THE FRACTURED INSERTER AND REVIEWED THE PATIENT WITH A RADIOGRAPH, WHICH DID NOT LOCATE ANY RETAINED FRACTURED PIECES. NO OTHER COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19461224 ↗InjuryMar 18, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF INSERTER WAS FRACTURED DURING USE, AND THE FRACTURED PIECE OF INSERTER HAS BEEN RETAINED IN THE PATIENT'S BODY. THIS HAPPENED WITH 2 INSERTERS; A PIECE FROM EACH IS STILL WITHIN THE PATIENT. NO FURTHER INFORMATION IS KNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 18920234 ↗MalfunctionOct 31, 2023Fracture; Expulsion; Material Twisted/Bent; Fracture; Expulsion; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE, THE ANCHOR DID NOT SUCCESSFULLY IMPLANT INTO THE BONE. THE SURGICAL TECHNIQUE WAS FOLLOWED, AND THE BONE WAS DRILLED 1.4MM, BUT WHEN THE ANCHOR WAS INSERTED, IT DID NOT REMAIN AND PULLED OUT. IT WAS ALSO LATER NOTICED THAT THE FEEDER IS BENT, AND TWO PROTRUDING SUTURES ARE BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED AS RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18038115 ↗MalfunctionOct 13, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17929584 ↗InjuryAug 8, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 17480211 ↗InjuryJul 12, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 17305465 ↗InjuryJun 21, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 17172550 ↗MalfunctionDec 6, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE SUTURE OF THE DEVICE GOT FRACTURED. THE FRACTURED PIECES DID NOT RETAIN INSIDE PATIENT BODY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15924375 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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