CANNU-FLEX SILK 014208Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010025654), received between Mar 9, 2021 and Mar 11, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K921481); 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 16, 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.

• MalfunctionMar 11, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BEFORE AN ARTHROSCOPY, SCREWS OF SIZE 6MM X 20MM WERE CONTAINED IN A PACKAGE OF 6MM X 30MM SIZE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LOT OF SMITH AND NEPHEW BACK-UP DEVICE WITH A 10 MINUTES DELAY. NO PATIENT INJURIES 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11467112 ↗
• MalfunctionMar 11, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SCREW CANNU-FLEX PACKAGE CONTAINED A SCREW SIZE 6MM X 20MM BUT IT WAS ORDER SCREWS OF 6MM X 30MM INSTEAD. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11461772 ↗
• MalfunctionMar 11, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SCREW CANNU-FLEX PACKAGE CONTAINED A SCREW SIZE 6MM X 20MM BUT IT WAS ORDER SCREWS OF 6MM X 30MM INSTEAD. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11461770 ↗
• MalfunctionMar 11, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SCREW CANNU-FLEX PACKAGE CONTAINED A SCREW SIZE 6MM X 20MM BUT IT WAS ORDER SCREWS OF 6MM X 30MM INSTEAD. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11461769 ↗
• MalfunctionMar 10, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, WHEN OPENING A STERILE PACKAGE OF "6MM X 30MM SCREWS"'; A SIZE OF 6MM X 20MM SCREW WERE CONTAINED INSTEAD OF THE ONE OF SIZE "6MM X 30MM". NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11455149 ↗
• MalfunctionMar 10, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, WHEN OPENING A STERILE PACKAGE OF "6MM X 30MM SCREWS"'; A SIZE OF 6MM X 20MM SCREW WERE CONTAINED INSTEAD OF THE ONE OF SIZE "6MM X 30MM". NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11455148 ↗
• MalfunctionMar 10, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, WHEN OPENING A STERILE PACKAGE OF "6MM X 30MM SCREWS"'; A SIZE OF 6MM X 20MM SCREW WERE CONTAINED INSTEAD OF THE ONE OF SIZE "6MM X 30MM". NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11455142 ↗
• MalfunctionMar 10, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, WHEN OPENING A STERILE PACKAGE OF "6MM X 30MM SCREWS"'; A SIZE OF 6MM X 20MM SCREW WERE CONTAINED INSTEAD OF THE ONE OF SIZE "6MM X 30MM". NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11455139 ↗
• MalfunctionMar 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY (ACL OR OTHER) SET UP OR INSPECTION OF SCR CNFLX 1.0 6 X 30 STER IT WAS FOUND THAT A SIZE OF 6 MM X 20 MM SCREWS WERE CONTAINED IN A STERILE PACKAGE INSTEAD OF A SIZE OF 6 MM X 30 MM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LOT OF BACK-UP DEVICE. THIS WAS FOUND BEFORE THE PROCEDURE, NO PATIENT INJURIES AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11448623 ↗
• MalfunctionMar 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY (ACL OR OTHER) SET UP OR INSPECTION OF SCR CNFLX 1.0 6 X 30 STER IT WAS FOUND THAT A SIZE OF 6 MM X 20 MM SCREWS WERE CONTAINED IN A STERILE PACKAGE INSTEAD OF A SIZE OF 6 MM X 30 MM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LOT OF BACK-UP DEVICE. THIS WAS FOUND BEFORE THE PROCEDURE, NO PATIENT INJURIES AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11448588 ↗
• MalfunctionMar 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY (ACL OR OTHER) SET UP OR INSPECTION OF SCR CNFLX 1.0 6 X 30 STER IT WAS FOUND THAT A SIZE OF 6 MM X 20 MM SCREWS WERE CONTAINED IN A STERILE PACKAGE INSTEAD OF A SIZE OF 6 MM X 30 MM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LOT OF BACK-UP DEVICE. THIS WAS FOUND BEFORE THE PROCEDURE, NO PATIENT INJURIES AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11448571 ↗
• MalfunctionMar 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY (ACL OR OTHER) SET UP OR INSPECTION OF SCR CNFLX 1.0 6 X 30 STER IT WAS FOUND THAT A SIZE OF 6 MM X 20 MM SCREWS WERE CONTAINED IN A STERILE PACKAGE INSTEAD OF A SIZE OF 6 MM X 30 MM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LOT OF BACK-UP DEVICE. THIS WAS FOUND BEFORE THE PROCEDURE, NO PATIENT INJURIES AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11448570 ↗
• MalfunctionMar 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY (ACL OR OTHER) SET UP OR INSPECTION OF SCR CNFLX 1.0 6 X 30 STER IT WAS FOUND THAT A SIZE OF 6 MM X 20 MM SCREWS WERE CONTAINED IN A STERILE PACKAGE INSTEAD OF A SIZE OF 6 MM X 30 MM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LOT OF BACK-UP DEVICE. THIS WAS FOUND BEFORE THE PROCEDURE, NO PATIENT INJURIES AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11448560 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K921481. One submission often covers many models, so check the product and lot details in each record.

• Z-1510-2021 · Apr 8, 2021 · Terminated
  CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstructi