CONMED 16.1018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854037270), received between Jun 3, 2025 and Jun 3, 2025 — classified as 1 malfunction.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT 16.1018, SUTURE RETRIEVAL FORCEPS, ARTHROSCOPIC 3.4 MM X 130 MM DEVICE WAS BEING USED DURING A SHOULDER BANKART PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿THE TIP OF OUR SUTURE RETRIEVER BROKE, THE TIP OF THE SUTURE RETRIEVER BROKE WHILE THE SURGEON WAS HOLDING AND PULLING THE TISSUE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE AND IT WAS RETRIEVED THROUGH USE OF A SUCTION DEVICE. THE CURRENT STATUS OF THE PATIENT IS "FINE". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130793 ↗