Knot MManipulator, Shoulder 210835Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10818674021958), received between Feb 16, 2021 and Jun 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC BANKART REPAIR PROCEDURE TO TREAT A DISLOCATION OF THE SHOULDER ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE SNAPPED WHEN IT WAS HELD BY A KNOT MANIPULATOR DEVICE TO MAKE A KNOT WITH AN UNKNOWN ANCHOR DEVICE. THE UNKNOWN ANCHOR DEVICE WAS LEFT IN THE PATIENT DUE TO SUTURE BREAKAGE. ANOTHER UNKNOWN ANCHOR DEVICE WAS USED AS A REPLACEMENT AND INSERTED INTO A NEW BURR HOLE TO MAKE A KNOT BUT THE SUTURE SNAPPED AGAIN WHEN IT WAS HELD BY THE MANIPULATOR. ONE OF THE TWO SUTURES ON THE SECOND UNKNOWN ANCHOR DEVICE WAS BROKEN, BUT THE OTHER ONE WAS USED FOR SUTURING. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30 MINUTES OF DELAY. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN . THE DEVICES WERE BRAND NEW AND THEIR FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086098 ↗
• MalfunctionFeb 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SHOULDER KNOT MANIPULATOR DEICE BROKE A SUTURE WHILE TYING THE KNOTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334296 ↗