JuggerStitch® 110024772Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of JuggerStitch (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet JuggerStitch soft tissue fastener is used to secure tissue during surgery. Most of the 37 reports describe the device breaking or fracturing during placement, with needle or handpiece fragments sometimes left in the patient and later removed in a follow-up operation; a few describe packaging problems or the device failing to fire. Reports mention7 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
- 36
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00880304690066), received between Mar 27, 2020 and Jan 27, 2026 — classified as 7 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 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
- Fracture22
- Failure to Advance4
- Packaging Problem3
- Break2
- Separation Failure2
- Activation Failure1
- Detachment of Device or Device Component1
- Difficult or Delayed Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Foreign Body In Patient5
- No Consequences Or Impact To Patient2
- Pain2
- Cyst(s)1
- Foreign Body Reaction1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE NEEDLE FRACTURED INTRA-OPERATIVELY DURING IMPLANT PLACEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24191568 ↗MalfunctionSep 15, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE DEVICE BROKE WHILE BEING PLACED ONTO THE KNEE DURING A PROCEDURE.FURTHER DILIGENCE RECEIVED INDICATES THAT THE HANDPIECE FRACTURED AND NOT THE TIP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23059313 ↗MalfunctionAug 6, 2025Fracture; Fracture
IT WAS REPORTED THAT WHEN THE WHEN THE SCRUB NURSE WAS HANDED THE DEVICE IT WAS FOUND THAT THE IMPLANT WAS FRACTURED AND THE THREADS WERE LOOSE. THE DEVICE WAS NOT USED BY THE SURGEON. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22728537 ↗MalfunctionJul 16, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE FOR A MENISCAL PROCEDURE, AFTER THE FIRST SHOT IT WAS FOUND THAT THE NEEDLE WAS LOOSE. SUBSEQUENTLY, WHEN TRYING TO REINSERT IT FOR THE SECOND SHOT, IT WAS NOTICED THAT IT WAS BROKEN AT 90 DEGREES. 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 22519346 ↗MalfunctionNov 18, 2024Tear, Rip or Hole in Device Packaging; Premature Separation; Tear, Rip or Hole in Device Packaging; Premature Separation
IT WAS REPORTED THAT WHEN THE PRODUCT WAS OPENED THE IMPLANT WAS PREMATURELY OUTSIDE OF THE NEEDLE ALREADY. THERE WAS NO REPORT OF DAMAGE TO THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20706257 ↗MalfunctionNov 13, 2024Fracture; Fracture
IT WAS REPORTED THAT THE NEEDLE OF THE JUGGERSTITCH FRACTURED DURING USE. THE FRACTURED PIECES WERE REMOVED. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20671148 ↗InjuryNov 12, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE LIGAMENT SURGERY APPROXIMATELY A MONTH AND A HALF AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE A PIECE OF THE FRACTURED NEEDLE FROM THE INSTRUMENT THAT WAS RETAINED BY THE PATIENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 20662655 ↗MalfunctionSep 17, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY TO REPAIR MENISCUS THAT THE JUGGERSTITCH IMPLANT BROKE THE INSERTER. THERE WAS NO REPORTED HARM OR INJURY TO PATIENT AND NO REPORTED DELAY. DUE DILIGENCE COMPLETE FOR THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236078 ↗MalfunctionApr 18, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PRODUCT WAS RECEIVED DAMAGED. 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 AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19135140 ↗MalfunctionJan 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PIERCING NEEDLE DETACHED DURING THE INSTALLING OF THE FIRST ANCHOR AND DURING EVALUATION OF THE PRODUCT, IT WAS FOUND THAT THE NEEDLE HAD FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18572304 ↗InjuryDec 28, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18409998 ↗InjuryOct 31, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) DUE TO UNKNOWN REASONS. IT WAS DISCOVERED THAT THE PATIENT HAD A METAL BODY IN THE KNEE JOINT. NO FURTHER DETAILS WERE GIVEN, EXCEPT A PHOTO WHICH SHOWS THE RETAINED FRACTURED PIECE WAS REMOVED ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: Cyst(s); Foreign Body In Patient; Foreign Body Reaction; Pain
MAUDE report 18039501 ↗MalfunctionOct 25, 2023Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18003156 ↗MalfunctionOct 25, 2023Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18003148 ↗MalfunctionOct 16, 2023Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING, AS THE STERILITY OF THE PACKAGING WAS DAMAGED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17939368 ↗MalfunctionSep 15, 2023Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT THE ANCHOR DIDN¿T DEPLOY DURING A PROCEDURE. NO HARM OR IMPACT TO THE PATIENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17756959 ↗MalfunctionSep 5, 2023Failure 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 17686163 ↗MalfunctionMay 16, 2023Failure to Advance; Material Twisted/Bent; Failure to Advance; 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 16939906 ↗InjuryMay 16, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 16939849 ↗InjuryMay 16, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 16939831 ↗MalfunctionMay 12, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE TIP OF THE INSERTER FRACTURED DURING PLACEMENT OF THE SECOND ANCHOR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE HOWEVER IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16918284 ↗MalfunctionApr 17, 2023Fracture; Fracture
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755274 ↗MalfunctionApr 4, 2023Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING THE PROCEDURE. 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 AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16673693 ↗MalfunctionApr 4, 2023Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING THE PROCEDURE. 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 AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16673674 ↗MalfunctionMar 29, 2023Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE NEEDLE OF JUGGERSTITCH STRAIGHT IMPLANT FRACTURED DURING THE IMPLANTATION. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16638505 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
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- 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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