JuggerKnot Soft Anchor SP99529BRecalls & reported problems
Riverpoint Medical, LLC · Soft Anchor · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840277402431), received between Apr 10, 2024 and Apr 10, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
ACCORDING TO THE REPORTER: "ALL-SUTURE ANCHOR INDICATED FOR RCR REPAIR. ON (B)(6) 2024 DR. (B)(6) , USED THE PRODUCT ABOVE, AND IT WAS UNSATISFACTORY. AS DR. (B)(6) WAS HOLDING THE ANCHOR THE HUMERAL HEAD AND HIS FELLOW WAS APPLYING FORCE WITH A MALLET, THE ANCHOR INSERTER BENT AND BROKE ON TWO OCCASIONS. THE BEND WAS SIGNIFICANT LEFT THE PRODUCT DAMAGED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19084312 ↗MalfunctionApr 10, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
ACCORDING TO THE REPORTER: "ALL-SUTURE ANCHOR INDICATED FOR RCR REPAIR. ON (B)(6)2024 DR. (B)(6) USED THE PRODUCT ABOVE, AND IT WAS UNSATISFACTORY. AS DR.(B)(6) WAS HOLDING THE ANCHOR THE HUMERAL HEAD AND HIS FELLOW WAS APPLYING FORCE WITH A MALLET, THE ANCHOR INSERTER BENT AND BROKE ON TWO OCCASIONS. THE BEND WAS SIGNIFICANT LEFT THE PRODUCER DAMAGED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19083166 ↗MalfunctionApr 10, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
ACCORDING TO THE REPORTER, "ATTACHED IS THE EVENT INFORMATION FROM THE 3 BROKEN JUGGERNAUTS AT (B)(6) HOSPITAL. I WILL ALSO ATTACH PICTURES OF THE BROKEN PRODUCTS IF THAT HELPS. WE HAVE TRIED 6X WITH THIS PRODUCT, ALL ANCHORS HAD THE SAME LOT # 23081820, 3 WERE SUCCESSFUL AND 3 FAILED. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081910 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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