NA 013562Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 23596010091141), received between Jul 24, 2020 and Jan 6, 2026 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Break; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE BONE TUNNEL PLUG LARGE 10-11MM, UPON OPENING THE TRAY, IT WAS DISCOVERED THAT THE PLUG WAS BROKEN INTO SEVERAL PIECES INSIDE THE TRAY; 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 23981522 ↗
• MalfunctionJan 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, A BONE TUNNEL PLUG FRACTURED INSIDE THE PATIENT, LEAVING A PIECE IN THE BONE TUNNEL, IT WAS REMOVED PIECE BY PIECE USING FORCEPS. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959360 ↗
• InjurySep 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PCL RECONSTRUCTION SURGERY, THE BONE PLUG TUNNEL 10/11MM WAS USED THEREAFTER, BUT IT ALSO BROKE IN HALF. THE 2 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 22986018 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BONE TUNNEL PLUG BROKE WHEN ENTERING THE TIBIAL TUNNEL. NO PIECES WERE LEFT IN THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846237 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BONE TUNNEL PLUG BROKE DURING TIBIAL TUNNEL CLEANING. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669068 ↗
• MalfunctionAug 23, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, A PERFORATION WAS PERFORMED IN THE TIBIA AND THE BONE TUNNEL PLUG FRACTURED INSIDE THE HOLE WHEN IT WAS INSERTED. THE FRAGMENTS WERE REMOVED USING GRASPER AND SHAVER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055344 ↗
• MalfunctionJun 13, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BONE TUNNEL PLUG, WAS IN VERY POOR CONDITION AND BROKE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532582 ↗
• MalfunctionMay 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE 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 19399197 ↗
• MalfunctionMar 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE SURGEON USED THE BONE TUNNEL PLUG (SPIGOTS) 10MM INTO THE TIBIAL HOLE AFTER PREPARATION TO STOP WATER FROM EXITING THE JOINT AND ONCE HE REMOVED IT, THE SPIGOTS CRUMPLED INTO PIECES AND BROKE INSIDE THE PATIENT JOINT. THE SURGEON THEREFORE SPENT APPROXIMATELY 20 MINUTES EXTRA OF INTRAOPERATIVE TIME TO REMOVE THE SPIGOTS PIECES INSIDE THE PATIENT USING AN ARTHROSCOPIC GRASPER AND SUCTION. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905585 ↗
• 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 18268135 ↗
• InjuryNov 9, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN THE FEMORAL TUNNEL WAS MADE, IN ORDER TO PREVENT SERUM LEAKAGE, THE SPECIALIST INSERTED A BONE TUNNEL PLUG. HOWEVER, WHEN IT WAS TIME TO REMOVE IT, THE TIP STAYED INSIDE. ALL THE PIECES WERE REMOVED. PATIENT´S HEALTH CONDITION IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15764211 ↗
• InjuryAug 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 15299154 ↗
• InjuryApr 22, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE USING A BONE TUNNEL PLUG, WHEN THE FEMORAL AND TIBIAL TUNNEL WERE MADE, THE DOCTOR DECIDED TO RELOCATE THE FEMORAL PIN AND THEREFORE USED A 10MM TIBIAL PLUG. AT THE TIME OF REMOVING THE PLUG, IT FRACTURED INSIDE THE JOINT. IT WAS MENTIONED THAT NO EXCESSIVE FORCE WAS USED WHEN REMOVING THE PLUG, IT WAS DONE BY HAND. AN ATTEMPT WAS MADE TO REMOVE THE FRAGMENT OF THE PLUG THAT WAS LEFT INTERARTICULAR WITH FORCEPS, AND IT BROKE AGAIN INTO MULTIPLE SMALL PARTS. AN EXHAUSTIVE WASHING OF THE JOINT WAS PERFORMED AND ALL THE FRAGMENTS WERE REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A SURGICAL DELAY OF 30 MIN WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14184288 ↗
• InjuryOct 3, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SURGERY RED DYE WAS COMING OFF THE LETTERING AT THE END OF THE PLUG CONTINUALLY AS POWDER. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. NO DELAY WAS REPORTED. NO OTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10624299 ↗
• InjuryAug 8, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BONE TUNNEL PLUG BROKE INSIDE THE PATIENT CAUSING SURGICAL COMPLICATION AND GENERATING A DELAY OF APPROXIMATELY HALF AN HOUR. THE PIECES WERE REMOVE FROM THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETED THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10383084 ↗
• InjuryJul 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ARTHROSCOPY SURGERY, THE BONE TUNNEL PLUG WAS PLACED IN ORDER TO NOT MAKE SERUM FROM THE TUNNEL, FOLLOWING THE PATIENT'S KNEE WAS BENT, THE PLUG BROKE. A PIECE OF THE PLUG WAS INSIDE THE TUNNEL, BUT IT WAS REMOVED SUCCESSFULLY AND THERE WAS NO NEED TO USE A BACKUP. THERE WAS A DELAY OF UNDER 30 MIN, THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10323381 ↗