CONCEPT GRAFIX TS8850Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854018255), received between Nov 20, 2024 and May 11, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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.

• MalfunctionMay 11, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE TS8850, CONCEPT GRAFIX TENDON STRIPPER, 7.0 MM DEVICE WAS USED IN AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2026, AND ¿DURING THE HARVESTING OF THE SEMITENDINOUS TENDON, THE INSTRUMENT BROKE AT THE TIP¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF A MITEK TENDON STRIPPER AND A DELAY OF 5 MINUTES. FURTHER ASSESSMENT FOUND THE DEVICE FRAGMENTED AND FELL INTO THE SURGICAL SITE. ALL FRAGMENTS WERE RETRIEVED USING A KOCHER. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT, WHOSE CURRENT STATUS IS REPORTED AS "ALL GOOD". THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137691 ↗
• MalfunctionApr 16, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE TS8850, CONCEPT GRAFIX TENDON STRIPPER, 7.0 MM WAS BEING USED ON (B)(6) 2026 AND ¿THE SURGICAL TECHNOLOGIST INFORMED THAT UPON INSERTION OF THE STRIPPER FOR GRAFT HARVESTING, THE DEVICE FRACTURED INSIDE THE PATIENT¿S LEG. THE BROKEN MATERIAL WAS SUCCESSFULLY RETRIEVED WITHOUT CAUSING HARM TO THE PATIENT.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT. 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 24894404 ↗
• InjuryNov 20, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, TS8850, CONCEPT GRAFIX TENDON STRIPPER, 7.0 MM, WAS BEING USED DURING AN ACL PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE TIP OF THIS TS8850 WAS BROKEN DURING GRAFT CUTTING.¿. FURTHER REPORTING STATES, ¿MORE INCISION TO TAKE OUT THE BROKEN TIP.¿ THE PROCEDURE WAS COMPLETED WITH ANOTHER TENDON STRIPPER. MORE INCISION WAS REQUIRED TO REMOVE THE TIP. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF ¿MORE INCISION¿ REQUIRED TO RETRIEVE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733158 ↗