ENDOBUTTON 7208678Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 03596010591265), received between Aug 3, 2017 and Mar 30, 2026 — classified as 15 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH ACL REPAIR, WHILE PASSING A GUIDE WIRE TO CREATE TIBIAL TUNNELS USING THE ULTRABUTTON TECHNIQUE, ONE (1) DRILL TIP PASSING PIN BROKE IN HALF INSIDE THE KNEE JOINT WHERE THE GUIDE WIRE BENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724732 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHEN STARTED DRILLING WITH ONE (1) DRILL TIP, THE PATIENT'S BONE WAS VERY HARD AND WHEN FORCING, THE TIP BROKE. IT WAS COMPLETELY REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416909 ↗
• MalfunctionDec 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHILE DRILLING THROUGH A FEMORAL GUIDE USING THREE (3) UNITS OF A PIN PASSING DRILL TIP, METAL SHAVINGS WERE VISIBLE IN THE JOINT. ALL DEBRIS WAS REMOVED FROM THE PATIENT WITH SUCTION, AND THE PATIENT WAS NOT HARMED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923470 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHILE INITIATING THE TIBIAL TUNNEL WITH THE GUIDE WIRE, A PIN PASSING DRILL TIP BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED WITH GRASPER FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849624 ↗
• MalfunctionSep 2, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN DRILLED THROUGH IT WITH THE PIN PASSING DRILL, IT RELEASED METAL SHAVINGS. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945668 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE PASSING PIN BROKE, AND THE IMPLANT THAT WAS INSERTED INSIDE THE PATIENT WAS COMPLETELY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. IT WAS INDICATED THAT THE DOCTOR'S TECHNIQUE CONTRIBUTED TO THE DEVICE'S BREAKAGE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22598216 ↗
• MalfunctionJul 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN ACL REPAIR PROCEDURE, WHILE DRILLING THE TIBIA WITH THE PIN PASSING DRILL TIP, THE DOCTOR MOVED HER HAND SLIGHTLY, CUTTING THE WIRE. THE PIECES WERE REMOVED FROM THE PATIENT USING AN ARTHROSCOPIC TWEEZER. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW 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 22588543 ↗
• MalfunctionMay 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL KNEE ARTHROSCOPY PROCEDURE, THE PIN PASSING DRILL TIP GUIDE WIRE BROKE. THE PIECE OF THE WIRE WAS COMPLETELY REMOVED FROM THE PATIENT WITH A KELLY CLAMP. 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 22085101 ↗
• MalfunctionMay 16, 2025Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY, THE GUIDE WIRE AT THE DRILL TIP WAS DAMAGED AND WORN BY THE DRILL. THE DOCTOR LIKELY MOVED ITS POSITION WHILE IT WAS BEING USED TO MAKE THE TUNNEL, CAUSING THE DAMAGE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038597 ↗
• MalfunctionNov 17, 2024Flaked; Flaked

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN PLACING THE OFFSET GUIDE AND PASSING THE PIN DRILL IT WAS VISUALIZED METAL SHAVINGS INSIDE THE PATIENT'S JOINT. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THE BROKEN PIECES WERE RETRIEVE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702937 ↗
• MalfunctionAug 23, 2024Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE PASSING PIN WAS SHAVEN THROUGH TWO THIRDS OF THE DIAMETER WHEN USING THE STEPPED ROUTER OVER IT, WHICH LEFT THE TUNNEL AND JOINT WITH MULTIPLE METAL SHAVINGS. THE OBVIOUS METAL SHAVINGS WERE CAREFULLY REMOVED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055500 ↗
• MalfunctionAug 23, 2024Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE PASSING PIN WAS SHAVEN THROUGH TWO THIRDS OF THE DIAMETER WHEN USING THE STEPPED ROUTER OVER IT, WHICH LEFT THE TUNNEL AND JOINT WITH MULTIPLE METAL SHAVINGS. THE OBVIOUS METAL SHAVINGS WERE CAREFULLY REMOVED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055481 ↗
• MalfunctionAug 22, 2024Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE PASSING PIN WAS SHAVEN THROUGH TWO THIRDS OF THE DIAMETER WHEN USING THE STEPPED ROUTER OVER IT, WHICH LEFT THE TUNNEL AND JOINT WITH MULTIPLE METAL SHAVINGS. THE OBVIOUS METAL SHAVINGS WERE CAREFULLY REMOVED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027318 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, WHEN THE WIRE WAS PASSED, RESISTANCE WAS NOTICED FROM THE PIN PASSING DRILL TO MILL THE CANAL AND THE WIRE BROKE. THE BROKEN PIECE WAS SUCCESSFULLY REMOVE WITH TWEEZERS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY OF 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962201 ↗
• MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, UPON RETURNING THE PIN PASSING DRILL, IT WAS OBSERVED THAT THE EYELET OF THE PASSING PIN HAD BECOME DETACHED AND REMAINED LODGED WITHIN THE DRILL CHAMBER. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367965 ↗
• InjuryFeb 23, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AT THE TIME OF PASSING THROUGH THE FEMUR FOR THE TUNNEL, THE LOW PROFILE DRILL BIT WAS INSERTED TO TUNNEL THE GRAFT, AND IT WAS NOTICED THAT THE PIN PASSING DRILL TIP WAS WORN, WHEN THE DRILL BIT PASSED THROUGH IT TO MAKE THE TUNNEL AND BEGAN TO RELEASE PARTICLES OF THE PIN MATERIAL LEAVING THE MATERIAL DISPERSED IN THE PATIENT'S JOINT. IT WAS REPORTED THAT THE PATIENT CURRENT STATUS IS STABLE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767748 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE WITH ACL AND FLEXORS, AT THE TIME THE TIBIA WAS PERFORATED, THE WIRE FROM PIN PASSING DRILL TIP WAS AMPUTATED INSIDE THE TIBIAL CANAL. THE WIRE WAS REMOVED FROM THE PATIENT USING TWEEZERS AND PLIERS. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THERE WAS A 10-MINUTE SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712754 ↗
• MalfunctionFeb 2, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY WITH ACL FLEXORS, THE PIN PASSING DRILL TIP BROKE INSIDE THE FEMORAL CANAL. THE SURGEON REMOVED THE MATERIAL FROM INSIDE THE PORTAL WITH THE HELP OF STRAIGHT KELLY FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO HARM TO THE PATIENT'S HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631542 ↗
• MalfunctionJan 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE PIN PASSING DRILL TIP SNAPPED UPON THE TUNNEL REAMING FOR ACL, THE DEVICE BROKE INSIDE THE PATIENT, AND THE BROKEN PIECES WERE REMOVED USING SHAVER SUCTION. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489228 ↗
• MalfunctionJan 8, 2024Flaked; Fracture; Material Deformation; Flaked; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A PIN PASSING DRILL TIP ATE THE PIN WITH EYELET AFTER IT WAS PASSED. WHEN A GUIDE WAS PASSED IN THE TIBIA, IT WAS SEEN THAT THE GUIDE WAS RELEASING METAL, EVEN THOUGH THE ONLY THING IT WAS PASSING THROUGH WAS BONE AND IT HAD NO CONTACT WITH ANY HARD SURFACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464624 ↗
• MalfunctionJan 8, 2024Flaked; Fracture; Material Deformation; Flaked; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A PIN PASSING DRILL TIP ATE THE PIN WITH EYELET AFTER IT WAS PASSED. WHEN A GUIDE WAS PASSED IN THE TIBIA, IT WAS SEEN THAT THE GUIDE WAS RELEASING METAL, EVEN THOUGH THE ONLY THING IT WAS PASSING THROUGH WAS BONE AND IT HAD NO CONTACT WITH ANY HARD SURFACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464620 ↗
• InjurySep 25, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE PASSING DRILL BROKE AWAY AND WAS LEFT IN THE BONE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. NO REPORTED ADVERSE OUTCOME TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17808150 ↗
• MalfunctionAug 7, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING ACL SURGERY, AT THE MOMENT OF INTRODUCING THE FEMORAL DRILL BIT ON THE PIN PASSING DRILL, METAL SHAVINGS CAME OUT. THE PROCEDURE WAS 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 17472260 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL REVISION, THREE PIN PASSING DRILLS FAILED THE SAME WAY. THE DRILL BROKE BECAUSE IT ENDED UP HITTING THE SCREW FROM THE PREVIOUS SURGERY. IT WAS NOT POSSIBLE TO VISUALIZE BY ARTHROSCOPY BECAUSE IT WAS BIOABSORBABLE; THE DOCTOR REQUESTED A FOURTH S+N DRILL TO END THE SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17205340 ↗
• MalfunctionNov 29, 2022Break; Break

  IT WAS REPORTED THAT THE PIN PASSING DRILL TIP WAS BROKEN. IT IS UNKNOWN WHEN THE EVENT HAPPENED RELATIVE TO SURGERY. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS A NON-SIGNIFICANT DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877476 ↗