NA 7210752Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010563279), received between Mar 1, 2020 and Jul 10, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, WHEN THE SURGEON WAS TRYING TO CATCH THE SUTURE, THE SNARE TOP HANDLE OF THE TFCC MENDER SUTURE SYSTEM KIT BROKE IN TWO PIECES. IT WAS ATTEMPTED TWICE, BUT BOTH PIECES OF THE SNARES IN THE SAME TFCC MENDER SUTURE SYSTEM KIT WERE EASILY BROKEN. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A FAST-FIX 360. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288265 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP BEFORE THE SURGERY, THE SUTURE LOOP HANDLE OF THE MENISCUS MENDER SET WAS BROKEN BEFORE IT WAS USED. NO PATIENT INJURIES OR SURGICAL DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940965 ↗
• MalfunctionAug 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP OF A KNEE SCOPE, THE HUBS AT THE END OF THE LOOPED PART OF THE TFCC MENDER, BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY 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 12330547 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPY TFCC REPAIR SURGERY, THE HANDLE OF THE MENDER DISPOSABLE BROKE OFF. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088697 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPY TFCC REPAIR SURGERY, THE HANDLE OF THE MENDER DISPOSABLE BROKE OFF. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088690 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY IN BOTH SET THE SUTURE LOOP HANDLE WAS BROKEN BEFORE IT WAS USED. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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

  MAUDE report 11164269 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY IN BOTH SET THE SUTURE LOOP HANDLE WAS BROKEN BEFORE IT WAS USED. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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

  MAUDE report 11164267 ↗
• MalfunctionOct 25, 2020Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, THE TFCC REPAIR BREAK AWAY FROM THE HUBS WHEN TRYING TO REMOVE FROM THE PLASTIC TRAY THEY ARE PACKAGED IN. NO SIGNIFICANT DELAY, AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10732165 ↗
• MalfunctionAug 14, 2020Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, WHEN THE MENISCUS MENDER PACK WAS OPENED, IT WAS FOUND THAT THE TWO METALS LOOPS WERE BROKEN OFF. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR 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 Known Impact Or Consequence To Patient

  MAUDE report 10410952 ↗
• MalfunctionAug 7, 2020Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR HORN MENISCAL REPAIR, THE NEEDLE OF THE MENDER SUTURE SYSTEMS KEPT BENDING UPON ENTRY INTO THE PATIENT'S JOINT, THIS WOULD NOT ALLOW THE SUTURE TO BE SHUTTLED THROUGH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10378390 ↗
• MalfunctionAug 7, 2020Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR HORN MENISCAL REPAIR, THE NEEDLE OF THE MENDER SUTURE SYSTEMS KEPT BENDING UPON ENTRY INTO THE PATIENT'S JOINT, THIS WOULD NOT ALLOW THE SUTURE TO BE SHUTTLED THROUGH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10378364 ↗
• MalfunctionMar 1, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, A SCREW BROKE WHILE BEING TAPPED. IT IS UNKNOWN WHETHER ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A BACK-UP SCREW WENT IN AND HELD. IT IS UNKNOWN HOW LONG SURGERY WAS DELAYED. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772687 ↗
• MalfunctionMar 1, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, A SCREW BROKE WHILE BEING TAPPED. IT IS UNKNOWN WHETHER ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A BACK-UP SCREW WENT IN AND HELD. IT IS UNKNOWN HOW LONG SURGERY WAS DELAYED. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772685 ↗