TWINFIX 7210116Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010482563), received between Nov 2, 2020 and May 30, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 30, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY TENODESIS PROCEDURE, AT THE TIME OF CUFF SUTURING, THE KNOT MANIPULATOR CUT THE THREAD 3 TIMES. ANOTHER ANCHOR HAD TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114403 ↗
• MalfunctionDec 20, 2024Material Deformation; Sharp Edges; Material Deformation; Sharp Edges

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE KNOT MANIPULATOR PUSHER CUT THE ANCHOR WIRES WHEN TIGHTENING THE KNOT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988826 ↗
• InjuryApr 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN THE KNOT MANIPULATOR QUICK-T WAS INTRODUCED INTO THE CAVITY THE ANCHOR WIRE WAS CUT IN ADVANCE. THE PROCEDURE WAS COMPLETED USING A CHANGE IN SURGICAL TECHNIQUE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166082 ↗
• InjuryNov 2, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT DURING SURGERY THE KNOT MANIPULATOR WAS CUTTING THE SUTURE INTRAOPERATIVE; THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED NOR IF THERE WAS ANY DELAY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10770784 ↗
• InjuryNov 2, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT DURING SURGERY THE KNOT MANIPULATOR WAS CUTTING THE SUTURE INTRAOPERATIVE; THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED NOR IF THERE WAS ANY DELAY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10770776 ↗