JuggerKnot Soft Anchors 110005307Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304568198), received between Jan 12, 2021 and Dec 17, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K110145, K150768, K973775); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE THREAD CAME AFTER THE INITIAL TENSIONING OF THE JUGGERKNOT. AT FIRST THE JUGGERKNOT WORKED FINE, BUT AFTER TYING IT WAS NOTED THAT THE THREAD BROKE WHILE THE ALL SUTURE PART REMAINED INSIDE THE BONE. ANOTHER JUGGERKNOT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23828699 ↗
• MalfunctionNov 10, 2025Material Twisted/Bent; Material Twisted/Bent

  ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511528 ↗
• MalfunctionJan 14, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT WHEN THEY OPENED THE PLASTIC WRAP ON THE BOX, ONE SIDE OF THE STERILE PEEL PACK WAS UNSEALED. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151912 ↗
• MalfunctionOct 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PRODUCT FRACTURED DURING THE PROCEDURE. ANOTHER PRODUCT WAS USED TO COMPLETE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002104 ↗
• MalfunctionJan 12, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING INSPECTION, THE PIECE WAS FOUND OPEN. NOT PATIENT INVOLVED. NO SURGERY OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 11154613 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110145, K150768, K973775. One submission often covers many models, so check the product and lot details in each record.

• Z-3252-2018 · Aug 3, 2018 · Terminated
  Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ank
• Z-1828-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
• Z-3109-2011 · Jul 21, 2011 · Terminated
  REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. Product Usage: The JuggerKnot Soft Anchors include various size ranges, each