Invisiknot 72204834Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556640227), received between Sep 17, 2020 and Nov 13, 2024 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP THE KIT INVISIKNOT ANKLE FRACTURE WAS OPENED AND THE STERILE PACKING WAS NOT SEALED PROPERLY. IT APPEARED TO BE RIPPED, MAKING IT UNSTERILE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678067 ↗
• MalfunctionSep 4, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE KIT INVISIKNOT WAS REMOVED FROM THE PATIENT. THE LATERAL BUTTON DID NOT FIT IN THE PLATE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135224 ↗
• MalfunctionSep 2, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING SET UP FOR AN ANKLE ARTHROSCOPY, THE INVISIKNOT KIT PACKAGING WAS TORE WHEN OPENING COMPROMISING THE DEVICE AS A RESULT. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20117995 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW PMS-366(INVISIKNOT), 1 PATIENT HAD DISRUPTION OF EXTERNAL OPERATION (SURGICAL) WOUND AFTER AN ANKLE PROCEDURE USING A INVISIKNOT KIT DEVICE. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Wound Dehiscence

  MAUDE report 17634285 ↗
• InjuryAug 24, 2023Migration; Migration

  IT WAS REPORTED THAT ON REGISTRY REVIEW (B)(6) (INVISIKNOT), 1 PATIENT HAD A DISPLACEMENT OF INTERNAL FIXATION DEVICE OF BONE IN THE LEFT LOWER LEG AND PAIN AFTER AN ANKLE PROCEDURE USING A INVISIKNOT KIT DEVICE. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 17616999 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW PMS-366(INVISIKNOT), 1 PATIENT HAD DISRUPTION IN THE SURGICAL WOUND, INFECTION IN THE DEEP INCISIONAL SURGICAL SITE AND IN OTHER UNSPECIFIED LOCATION AND PAIN AFTER AN ANKLE PROCEDURE USING A INVISIKNOT KIT DEVICE. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17616852 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE ORIF, THE MEDIAL BUTTON OF THE KIT INVISIKNOT ANKLE WAS SECURED ON THE TIBIA AND WHEN THE SURGEON WENT TO TIGHTEN DOWN THE SUTURE THE TIGHTROPE BROKE. THE PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569459 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ANKLE FRACTURE FIXATION WITH KIT INVISIKNOT, THE PATIENT HAD A REVISION SURGERY DUE TO PAINFUL IMPLANTS. THE OUTCOME OF THE PATIENT IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470168 ↗
• MalfunctionAug 27, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING SURGERY, THE PACKAGING OF THE INVISIKNOT ANKLE FRACTURE TORE WHEN IT WAS GOING TO BE USED AND IT GOT UNSTERILE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380014 ↗
• InjuryNov 9, 2020Break; Break

  IT WAS REPORTED THAT AT THE FIRST OPERATIVE APPOINTMENT ON (B)(6) 2020, IT WAS FOUND THAT THE INVISIKNOT BROKE AT THE TIB/FIB JOINT. THE PATIENT WAS SENT TO SURGERY AGAIN ON (B)(6) 2020 TO REMOVE THIS INVISIKNOT AND REPLACE WITH A SMITH AND NEPHEW SCREW. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. HE ANKLE WAS REVISED AND ANOTHER SCREW WAS REMOVED AND TWO SYNDESMOTIC SCREWS WERE ADDED. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Insufficient Information; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10807255 ↗
• MalfunctionSep 17, 2020Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE KIT INVISIKNOT ANKLE FRACTURE WAS GOING TO BE USED, BUT THE INSIDE PACKAGE WAS OPENED AND UNSTERILE. NO CASE WAS INVOLVED. BACK-UP DEVICE WAS AVAILABLE FOR THE UPCOMING CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10546803 ↗