JuggerKnot CM-99229BRecalls & reported problems
Riverpoint Medical, LLC · Soft Anchor · Class 2 · Implant
All models of JuggerKnot (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810020087253), received between Feb 18, 2022 and Jun 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
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
- Device Handling Problem1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2026Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE FOREIGN SUBSTANCE WHICH LOOKS LIKE A HAIR WAS FOUND INSIDE OF THE STERILE PACKAGE WHEN THE NURSE OPENED THE OUTER PACKAGE. THEREFORE, THE NURSE PREPARED A BACK UP PRODUCT FOR THE SURGERY. THE COMPLAINT PRODUCT IS UNOPENED PRODUCT.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669819 ↗MalfunctionFeb 18, 2022Device Handling Problem; Device Handling Problem
ACCORDING TO THE REPORTER, "2.9 JUGGERKNOTS WERE USED WITH PROPER TECHNIQUE DURING THE PROCEDURE. EACH ITEM ATTACHED FAILED TO PROPERLY DEPLOY WHEN ATTEMPTING TO PLACE ANCHOR INTO THE PATIENT. PRODUCT FAILURE DURING FOOT AND ANKLE SOFT TISSUE REPAIR (MODIFIED BROSTRUM) AND ANKLE SYNDESMOSIS ON (B)(6) 2022"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13564175 ↗
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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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