CONMED 97.10015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854018972), received between Aug 28, 2023 and Aug 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175585 ↗
• MalfunctionFeb 13, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 97.10015, 3.4MM X 130MM SUTURE HOOK, STRAIGHT, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿IT WAS REPORTED THAT THE TIP OF SUTURE HOOK WAS BROKEN DURING THE SURGERY. NO FRAGMENTS REMAINED INTO THE PATIENT'S BODY¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING FOUND THAT IT IS LIKELY THE FRAGMENTATION FELL INTO THE PATIENT AND WAS RETRIEVED. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED AS PLANNED USING AN ALTERNATIVE UNKNOWN DEVICE. 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 18694024 ↗
• MalfunctionAug 28, 2023Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICES, (B)(6), CRESCENT HOOK 3MM X 15MM AND THE 97.10015, 3.4MM X 130MM SUTURE HOOK, STRAIGHT WERE BEING USED ON (B)(6) 2023 DURING A BANKART REPAIR PROCEDURE AND ¿IT WAS REPORTED THAT TWO HOOK POINTS OF SUTURE HOOK I WERE DAMAGED. IT IS CONFIRMED THAT IT IS DAMAGED BECAUSE IT WAS PULLED OUT BY FORCE.¿ THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ¿ABOUT A 5 MINUTE DELAY¿. AFTER FURTHER ASSESSMENT IT WAS DISCOVERED THAT FOR BOTH DEVICES THE TIP SNAPPED OFF AND FELL INTO THE PATIENT AND THE FRAGMENTS WERE RETRIEVED. 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 17630358 ↗