JuggerKnot Soft Anchors 912031Recalls & 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
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00880304509627), received between Sep 8, 2021 and Sep 23, 2026 — classified as 11 injuries, 12 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.
Reports received per month
Most reported problems
Device problems
- Fracture18
- Material Twisted/Bent2
- Biocompatibility1
- Device Dislodged or Dislocated1
- Difficult or Delayed Activation1
- Expulsion1
- Incomplete or Missing Packaging1
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Foreign Body In Patient10
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 50870266 ↗MalfunctionApr 28, 2026Fracture
IT WAS REPORTED THAT DURING AN INITIAL SURGICAL PROCEDURE, A SOFT ANCHOR FRACTURED DESPITE THE APPLICATION OF THE PROPER SURGICAL TECHNIQUE. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SUTURE LINES FRACTURED; ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018681 ↗MalfunctionJan 15, 2026Difficult or Delayed Activation; Expulsion
IT WAS REPORTED THAT DURING A BANKART REPAIR SHOULDER PROCEDURE, THE SURGEON WAS USING A JUGGERKNOT 1.5 ANGLE AND THE ANCHOR DID NOT DEPLOY TO THE BONE AND RETURNED BACK. THERE WAS A 20 MINUTE DELAY. NO PATIENT CONSEQUENCES WERE REPORTED AS A 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 24085741 ↗InjuryNov 13, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23544665 ↗MalfunctionJul 15, 2025Positioning Problem; Positioning Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507417 ↗InjuryApr 17, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE INSERTER FRACTURED AND THE FRACTURED PIECE WAS RETAINED INSIDE THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 21860282 ↗InjuryFeb 6, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE INSERTER OF THIS COMPLAINT PRODUCT'S DEVICE WAS FRACTURED WHEN THE SURGEON INSERTED THE ANCHOR INTO THE PATIENT'S BURR HOLE. THE FRACTURED PIECE OF THE INSERTER HAS BEEN RETAINED IN THE PATIENT'S BODY. THERE WAS A SURGICAL DELAY OF FIFTEEN MINUTES AS A RESULT OF THE EVENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 21322587 ↗MalfunctionJan 29, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPLANTING THE ANCHOR THE TIP OF THE DEVICE FRACTURED AND PULLED THE ANCHOR OUT OF THE PATIENT'S BONE. THERE WAS NO REPORT OF FOREIGN BODY RETAINED OR HARM TO THE PATIENT. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21265992 ↗InjuryJan 17, 2025Biocompatibility; Biocompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21178783 ↗MalfunctionNov 26, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING SURGERY THAT THE TIP OF THE INSERTER WAS BENT AND THE ANCHOR COULDN'T BE IMPLANTED. THERE WAS NO HARM OR INJURY TO PATIENT. A DELAY OF APPROXIMATELY 15 MINUTES WAS REPORTED WHILE AN ALTERNATE DEVICE WAS SUBSTITUTED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20778180 ↗InjuryOct 28, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THAT THE DEVICE FRACTURED AND WAS RETAINED BY THE PATIENT. THERE WAS NO REPORTED HARM, INJURY, OR MEDICAL/SURGICAL INTERVENTION. THERE IS NO PLAN FOR ANY SURGICAL INTERVENTION TO REMOVE THE FOREIGN PARTICLE. A DELAY OF APPROXIMATELY 15 MINUTES WAS REPORTED WHILE THE SURGEON CONSIDERED COURSE OF ACTION WITH REGARDS TO THE RETAINED DEVICE. THE SURGERY WAS FINISHED USING THE SAME DEVICE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 20545323 ↗MalfunctionOct 23, 2024Incomplete or Missing Packaging; Missing Information; Incomplete or Missing Packaging; Missing Information
IT WAS REPORTED THAT WHEN THE PACKAGING WAS OPENED THE STERILE PACKAGING AND STICKERS WERE NOT INSIDE OF THE PACKAGING. THERE WAS NO REPORT OF HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20518099 ↗MalfunctionMay 17, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF INSERTER WAS FRACTURED DURING USE.IT IS UNKNOWN IF THE FRACTURED PIECE WAS RETAINED OR NOT WITHIN THE PATIENT. NO FURTHER INFORMATION IS KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19339545 ↗InjuryMay 7, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 19264999 ↗MalfunctionMar 18, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE INSERTER WAS FRACTURED. THE FRACTURED PIECE OF INSERTER WAS REMOVED FROM PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923446 ↗MalfunctionFeb 7, 2024Fracture; Material Twisted/Bent; Fracture; 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 18664404 ↗InjuryAug 30, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE INSERTER FRACTURED WHEN THE SURGEON TRIED TO IMPLANT THE ANCHOR INTO THE PATIENT'S BURR HOLE. THE FRACTURED TIP REMAINED INSIDE OF THE PATIENT; HOWEVER, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED SINCE THE EVENT OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 17649431 ↗MalfunctionJul 20, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17360712 ↗InjuryJan 3, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PRODUCT FRACTURED AND A PIECE REMAINS IN THE PATIENT'S WOUND. 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 16089313 ↗MalfunctionNov 28, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING THE SURGERY THE ANCHOR PULLED OUT WHEN THE SURGEON APPLIED TENSION TO THE SUTURE. THE TIP OF THE INSERTER WAS FRACTURED, AND ALL PIECES WERE RECOVERED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15868230 ↗InjurySep 28, 2022Fracture; Fracture
IT WAS REPORTED THAT THE JUGGERKNOT WAS USED IN AN INITIAL SURGERY, BUT THE TIP OF THE INSERTER WAS BROKEN AND THE ANCHOR COULD NOT BE PLACED, SO A NEW ANCHOR WAS INSERTED AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS, BUT THE BROKEN TIP OF THE INSERTER REMAINED IN THE BODY.
Patient problems: Foreign Body In Patient
MAUDE report 15497822 ↗MalfunctionApr 14, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY THE TIP OF THE INSERTER WAS FRACTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14112005 ↗InjurySep 8, 2021Fracture; Fracture
IT WAS REPORTED APPROXIMATELY TWO AND A HALF WEEKS AGO DURING A PROCEDURE, THAT THE INSERTER FRACTURED. THE FRACTURED PIECES REMAINED IN THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 12442999 ↗
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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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