CONMED TS8865Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854050323), received between Dec 13, 2024 and Mar 30, 2026 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 30, 2026Material Fragmentation

  THE DISTRIBUTOR REPORTED THAT THE THAT THE TS8865 TENDON STRIPPER, OPEN LOOP, DIAM. 6.5 MM, DEVICE WAS BEING USED ON (B)(6) 2026 DURING AN ACL PROCEDURE WHEN IT WAS REPORTED ¿WHILE USING THE DEVICE, IT BROKE AND PART OF IT REMAINED IN THE PATIENT AND TOOK ONE HOUR TO REMOVE.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND 30 MINUTES TO ONE HOUR OF DELAY. 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 24712180 ↗
• InjuryDec 13, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE TS8865 TENDON STRIPPER, OPEN LOOP, DIAM. 6.5 MM, WAS BEING USED ON (B)(6)2024 DURING A REVISION ACL & MENISCUS REPAIR PROCEDURE WHEN IT WAS REPORTED ¿THE SURGEON WAS DOING REVISION ACL AND WHILE HARVESTING THE GRAFT SEMITENDINOSUS THE TIP OF THE OPEN LOOP STRIPPER GOT DETACHED FROM THE SHAFT AND LEFT INSIDE THE PATIENT WHILE PULLING OUT THE STRIPPER. THIS INCIDENT WAS REPORTED BY OR STAFF WHILE DOING THE CLOSING AND SHARED THE FINAL PICTURES OF THE X RAY. IT WAS VERY UNFORTUNATE AND LATER THE PATIENT AGAIN GOT OPERATED AND THEY REMOVED THIS TIP FROM THE BODY.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE SECONDARY PROCEDURE WAS PERFORMED ON THE NEXT DAY (B)(6)2024. THE PATIENT STAYED IN THE HOSPITAL FOR 3 DAYS INSTEAD OF 2. IT WAS ALSO REPORTED THAT ¿THE PATIENT IS RECOVERING WELL AT HOME, FOLLOWING THE RECOMMENDED REHABILITATION PROGRAM.". THE PROCEDURE WAS COMPLETED WITH A 1 HOUR AND 30-MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT NEEDING AN ADDITIONAL SURGERY TO REMOVE THE FOREIGN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923664 ↗