NA 013560Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 23596010091127), received between Apr 23, 2019 and May 15, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THREE (3) WHITE TIBIAL FLOW RESTRICTOR BONE PLUG, BROKE OFF IN THE PATIENT'S TIBIA. THE BROKEN PIECES WERE REMOVED, NO BONE PLUG WAS ABLE TO BE USED AFTER THE EVENT. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324744 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BONE TUNNEL PLUG BROKE AFTER BEING INSERTED INTO THE PATIENTS TIBIA. IT BECAME VERY BRITTLE AND SHATTERED. THE BROKEN PIECES WERE REMOVED USING A GRASPER AND THE SHAVER WITH SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19073680 ↗
• MalfunctionMar 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A LCA RECONSTRUCTION, THE BONE TUNNEL PLUG FRACTURED WHEN IT WAS INSERTED INTO THE 9MM TUNNEL IN THE PATIENT'S TIBIA, THE PIECE DID NOT REMAIN INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942227 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THREE (3) BONE PLUGS BROKE AND DISINTEGRATED WHILE BEING INSERTED INTO THE TIBIAL TUNNEL, THE BROKEN PIECES WERE REMOVED BY USING CURETTES. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268087 ↗
• MalfunctionAug 25, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE THE BONE TUNNEL PLUGS WERE BEING TAKEN OUT OF THE ACL SETS AND BOTH, THE SMALL (B)(4) AND LARGE (B)(4) BROKE INTO TWO PARTS AS THEY WERE BEING TAKEN OUT OF THE SET. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299141 ↗
• MalfunctionJun 10, 2019Material Separation; Material Separation

  IT WAS REPORTED, DURING AN UNSPECIFIED SURGERY, THE BONE TUNNEL PLUG BROKE ITS TIP INSIDE THE JOINT. THE FRAGMENT WAS REMOVED. IT IS UNKNOWN IF/HOW THE SURGERY WAS COMPLETED. THE SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8684726 ↗
• MalfunctionApr 23, 2019Break

  IT WAS REPORTED THAT DURING TREATMENT DEVICE BROKE. ALL PIECES WERE REMOVED. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE OR IF THERE WAS DELAY ON THE PROCEDURE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8541671 ↗