NA 013561Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 23596010091134), received between Aug 20, 2019 and Apr 29, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN REMOVING THE PLUG BONE TUNNEL FROM THE TUNNEL, PART OF THE PLUG REMAINED IN THE JOINT, BREAKING APART. ALL THE DEBRIS WAS REMOVED THOROUGHLY WASHED TO CLEAN IT. IT WAS ALL COMPLETELY REMOVED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO PATIENT DAMAGE OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024361 ↗
• MalfunctionJan 6, 2026Break; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE PLUG BONE TUNNEL 9/10 MED BROKE INTO PIECES INSIDE THE EQUIPMENT AND WAS ALSO EMITTING A FOUL ODOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981523 ↗
• InjurySep 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PCL RECONSTRUCTION SURGERY, WHEN THE BONE PLUG TUNNEL 9/10MM WAS INSERTED INTO THE TIBIAL TUNNEL, THE BONE PLUG BROKEN IN HALF. THE BROKEN PIECES WITHIN THE TUNNEL WERE THEN PUSHED INTO THE POSTERIOR JOINT SPACE USING ANOTHER INSTRUMENT, AND THE SURGEON THEN TRIED TO REMOVE THE PIECES USING AN ARTHROSCOPIC GRASPER. HOWEVER, DUE TO THE PIECES BEING EXTREMELY BRITTLE, WHENEVER SURGEON WOULD TRY TO GRAB A HOLD OF THE PIECES USING THE GRASPER THEY WOULD BREAK APART FURTHER CAUSING NUMEROUS SMALL PIECES OF PLASTIC TO BE SCATTERED WITH THE JOINT. THE LARGER PIECES WERE REMOVED USING THE GRASPER, AND SOME OF THE SMALLER PIECES WERE SUCKED UP WITH THE SHAVER HANDPIECE, HOWEVER NOT ALL PIECES COULD BE REMOVED SUCCESSFULLY. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22985854 ↗
• MalfunctionOct 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY ACL, THE PLUG BONE TUNNEL FRACTURED WHILE ENTERING THE TIBIAL TUNNEL. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. NO DAMAGE CAUSED, THE PATIENT'S HEALTH CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370088 ↗
• InjuryJun 17, 2024Break; Break

  IT WAS REPORTED THAT, DURING ARTHROSCOPY, THE 9/10MM BONE PLUG SHATTERED INSIDE THE PATIENT¿S KNEE LEAVING NUMEROUS BITS AND PIECES OF PLASTIC FLOATING AROUND. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19554693 ↗
• MalfunctionMay 26, 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 19399195 ↗
• InjuryFeb 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, THE 9-10MM PLUG BONE TUNNEL DEVICE FRACTURED WHEN IT WAS INSERTED INTO THE 9MM TUNNEL, THE DISTAL FRAGMENT REMAINED INSIDE THE TUNNEL. ANOTHER INCISION HAD TO BE MADE TO INSERT A PIN THROUGH THE TUNNEL AND REMOVE FRAGMENT COMPLETELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682294 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, FOUR (4) 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 18268132 ↗
• MalfunctionAug 16, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A PART OF THE PLUG BONE TUNNEL FELL TO THE GROUND AFTER THE MENISCUS WAS SUTURED. THE OTHER PART OF THE PLUG WAS STILL INSIDE THE TUNNEL, IT WAS ATTEMPTED TO REMOVE THE REST OF THE PLUG THAT WAS INSIDE THE JOINT, BUT WHEN TRYING TO REMOVE IT, IT BROKE INTO MORE FRAGMENTS. ALL FRAGMENTS WERE REMOVED AFTER SEVERAL MINUTES, USING DIFFERENT TOOLS. SURGERY WAS COMPLETED AFTER A 20-MINUTE DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560866 ↗
• InjuryJul 5, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, WHEN THE BONE PLUG WAS GOING TO BE REMOVED FROM THE TIBIAL TUNNEL TO MAKE A LARGER PERFORATION, IT BROKE AND HALF OF IT REMAINED INSIDE THE PATIENT BUT IT WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916364 ↗
• InjuryApr 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, UPON INSERTING THE BONE PLUG INTO THE TIBIAL TUNNEL, THE SHAFT OF THE PLUG BROKE OFF IN THE TUNNEL. A SMALLER BONE PLUG WAS USED TO PUSH THE BROKEN PIECE FURTHER UP THE TUNNEL AND INTO THE JOINT SPACE TO RETRIEVE IT VIA THE PORTAL USING A GRASPER BUT WHEN ATTEMPTING TO GRASP, THE BROKEN PIECE WAS SO BRITTLE THAT IT DISINTEGRATED INTO NUMEROUS TINY PIECES. SOME OF THE PIECES WERE REMOVED USING A GRASPER AND THE SHAVER BUT IT IS UNKNOWN IF ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NON SIGNIFICANT SURGICAL DELAY BY FILLING THE TIBIAL BONE TUNNEL WITH A HAMSTRING TENDON AND INTERFERENCE SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14080218 ↗
• InjuryJan 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING USE, THE TIP OF THE PLUG BONE TUNNEL 9/10 MED BROKE IN THE TIBIAL TUNNEL. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13153502 ↗
• MalfunctionJan 7, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LCA PROCEDURE, THE PLUG BONE TUNNEL BROKE INSIDE THE PATIENT'S ARTICULATION. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO DELAY WAS REPORTED. IT WAS NOT REPORTED IF A SMITH & NEPHEW DEVICE WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9558269 ↗
• MalfunctionDec 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A KNEE PROCEDURE, THE SURGEON EFFECTIVELY LOADED AN ULTRABUTTON. HOWEVER, WHEN PULLING THE GRAFT IT TEARED. THERE WAS AN ENDOBUTTON CL ULTRA (10MM) AVAILABLE AND WAS USED AS BACKUP. NONETHELESS, THE SURGERY COMPLICATED GIVEN THAT THE MEDIUM BONE TUNNEL PLUG BEING USED FRACTURED INSIDE OF THE TIBIAL TUNNEL. THE FRAGMENT ROSE TO THE JOINT AND MADE IT ALMOST IMPOSSIBLE TO EXTRACT. IT IS UNKNOWN IF THERE WAS A BONE TUNNEL PLUG BACKUP. AFTER A 3 HOUR DELAY, THE JOINT WAS PRESUMED TO BE CLEAN OF FRAGMENTS. NO PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9528534 ↗
• MalfunctionAug 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY+LCA SURGERY THE DEVICE BROKE OFF INSIDE THE TIBIA TUNNEL, AS PER REPORTER THE BROKEN PIECES WERE RETRIEVED IMMEDIATELY WITH A SHAVE. NO PATIENT INJURIES OR DELAY REPORTED. SURGERY WAS FINISHED USING THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8910384 ↗