GraftMax KC8545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854042410), received between Nov 14, 2025 and Nov 14, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE KC8545, GRAFTMAX FLEX CHANNEL REAMER, 4.5 X 229 MM (9") DEVICE WAS USED IN A LEFT KNEE ARTHROSCOPY, ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, AUTOGRAFT QUADRICEPS PROCEDURE ON (B)(6) 2025, AND ¿WHEN. RESIDENT WAS DRILLING THE BUTTON TUNNEL IN THE FEMUR, A 4.5 MM FLEX CHANNEL REAMER FRACTURED. THE FLEXIBLE PORTION OF THE REAMER SEPARATED FROM THE STRAIGHT SHAFT AND SUBSEQUENTLY FRACTURED INTO TWO DISTINCT SEGMENTS. DR. SUCCESSFULLY RETRIEVED THE LARGER FRAGMENT USING A SNAP AND GENTLE BACK-MALLETING TECHNIQUE, FOLLOWED BY COMPLETE RETRIEVAL OF THE SMALLER FRAGMENT. ALL INSTRUMENT COMPONENTS WERE ACCOUNTED FOR, AND NO FRAGMENTS REMAINED WITHIN THE JOINT. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS. A NEW 4.5 MM REAMER WAS THEN UTILIZED TO COMPLETE THE REMAINING PORTION OF THE TUNNEL PREPARATION WITHOUT ISSUE.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE SAME DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 23553835 ↗
• MalfunctionNov 14, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE KC8545, GRAFTMAX FLEX CHANNEL REAMER, 4.5 X 229 MM (9") DEVICE WAS USED IN A LEFT KNEE ARTHROSCOPY, ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, AUTOGRAFT QUADRICEPS PROCEDURE ON (B)(6) 2025, AND ¿WHEN . RESIDENT WAS DRILLING THE BUTTON TUNNEL IN THE FEMUR, A 4.5 MM FLEX CHANNEL REAMER FRACTURED. THE FLEXIBLE PORTION OF THE REAMER SEPARATED FROM THE STRAIGHT SHAFT AND SUBSEQUENTLY FRACTURED INTO TWO DISTINCT SEGMENTS. DR. SUCCESSFULLY RETRIEVED THE LARGER FRAGMENT USING A SNAP AND GENTLE BACK-MALLETING TECHNIQUE, FOLLOWED BY COMPLETE RETRIEVAL OF THE SMALLER FRAGMENT. ALL INSTRUMENT COMPONENTS WERE ACCOUNTED FOR, AND NO FRAGMENTS REMAINED WITHIN THE JOINT. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS. A NEW 4.5 MM REAMER WAS THEN UTILIZED TO COMPLETE THE REMAINING PORTION OF THE TUNNEL PREPARATION WITHOUT ISSUE.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE SAME DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 23553834 ↗