SOFTSILK 014270Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010416971), received between Nov 5, 2018 and Nov 5, 2018 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE DISTAL TIP OF THE DRIVER BROKE OFF IN THE SCREW, THE PIECES WERE NOT REMOVED FROM THE PATIENT. THERE WAS NO BACKUP DEVICE AVAILABLE AND NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8037831 ↗

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