inforMED
MalfunctionFZT

CORDCUTTER

Received Jul 8, 2026 · Event occurred Jul 1, 2026

Report 1221934-2026-02935 · MDR key 25752289

Device

Generic name

Cutter, Surgical

Manufacturer

Depuy Mitek Llc Us

Catalog number

214646

Lot number

19F03

Product problems

  • Degraded
  • Difficult to Open or Close
  • Mechanical Jam

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE CORDCUTTER WAS LOCKED IN PLACE AND DID NOT CUT THE SUTURE. THE DEVICE WAS JAMMED AND DID NOT OPEN OR CLOSE TO CUT THE SUTURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED, AND NO CONCLUSION CAN BE DRAWN AT THIS TIME.