ACUFEX 7207193Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010253491), received between Apr 9, 2020 and Sep 10, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionSep 10, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE TIP OF THE DRIVER SNAPPED OFF WHEN INSERTING A RCI SCREW. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456313 ↗
• InjuryApr 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, WHILE USING THE CANNULATED DRIVER, THE END (TIP) OF THE SCREWDRIVER BROKE OFF INSIDE THE PATIENT. ALL PIECES WERE RECOVERED WITH THE USE OF FINE FORCEPS. THE PROCEDURE WAS COMPLETED WITH NO DELAY AND A BACKUP DEVICE WAS AVAILABLE. NO FURTHER 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 9945702 ↗

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