ENDOBUTTON 72202971Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 03596010654526), received between Aug 1, 2017 and Jul 8, 2026 — classified as 8 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (44 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH ACL, WHILE INSIDE THE PATIENT, WHEN CREATING THE TUNNEL FOR THE ULTRABUTTON, THE TIP OF ONE (1) FLEXIBLE DRILL BROKE. THE BIT TIP WAS REMOVED USING KELLY FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25749791 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE 4.5MM FLEXIBLE DRILL BROKE INSIDE THE PATIENT. THE PIECES WERE REMOVED FROM INSIDE THE PATIENT USING PLIERS. 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 24268074 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT, DURING A FEMORAL TUNNEL PERFORATION FOR A KNEE ARTHROSCOPY, THE DRILL ENDOSCOPIC CANNULA BROKE IN THE MIDDLE AT THE MOMENT THE SURGEON REVERSED THE DRILL. ONE PART FELL INTO THE CAVITY AND WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS RESUMED, WITH A DELAY OF LESS THAN 30 MINUTES, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630776 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE DRILL FLEXIBLE ENDOSCOPIC CANNULA (4.5 MM) BROKE INSIDE THE PATIENT¿S KNEE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE USING TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A 20-MINUTE SURGICAL DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458056 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FLEXIBLE DRILL BROKE, THE BREAK OCCURRED WHEN THE CONDYLE WAS BEING DRILLED. THE FLEXIBLE GUIDE HAD BEEN BENT BY FORCE USED BY THE DOCTOR, THEN THE DRILL BROKE INSIDE THE FEMORAL TUNNEL. THE FRAGMENTS WERE REMOVED BY INTRODUCING FROM THE OUTSIDE TO THE INSIDE FROM THE TIP OF THE GUIDE TOWARDS THE INTERCONDYLAR SPACE. THE PROCEDURE WAS COMPLETED USING A 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 22923451 ↗
• MalfunctionJul 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE FLEXIBLE DRILL BROKE WHEN PERFORMING THE FEMORAL TUNNEL. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19863283 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE FEMUR TUNNEL WAS MADE, THE FLEXIBLE DRILL BROKE INSIDE THE PATIENT, IT WAS DRILLED FROM THE OUTSIDE IN, AND THE BROKEN PIECE CAME OUT. NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT. 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 19812620 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FLEXIBLE DRILL BROKE. THE BROKEN PART WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904768 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE DRILL CANNULA 4.5MM DRILLED THE BONE, THE DRILL BIT BROKE AS THE BONE WAS VERY HARD. ALL THE DRILL BIT PIECES WERE REMOVED WITH AN HEMOSTAT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT 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 18056107 ↗
• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DRILL WAS DAMAGED, BROKEN DURING THE FIRST USE. THE PROCEDURE WAS COMPLETED WITH 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 17808594 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE FEMUR WAS BEING DRILLED, THE SURGEON FELT HIGH RESISTANCE WHEN TRYING TO MAKE THE TUNNEL WITH THE 4.5MM FLEXIBLE DRILL. THE REPORTED DEVICE BROKE IN THE PATIENT'S FEMUR. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH THE HELP OF TWEEZERS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO SURGICAL DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020902 ↗
• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, A FLEXIBLE DRILL BROKE, ITS FRAGMENTS WERE RECOVERED USING THE PIN GUIDE. SURGERY CONTINUED WITHOUT ANY DELAY WITH THE SAME DEVICE AS THE PART OF THE PROCEDURE WHERE IT WAS NEEDED HAD JUST FINISHED; THEREFORE THE ORIGINALLY DRILLED BONE WAS USED AND NO VOIDS WERE LEFT IN THE PATIENT. PATIENT´S HEALTH IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986622 ↗
• InjuryMar 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, AFTER USING THE CLANCY FLEXIBLE DRILL IT WAS FRACTURED INSIDE THE SLOTS. NO PIECES WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496721 ↗
• InjuryMar 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN STARTING TO USE THE FLEXIBLE DRILL, IT MADE A NOISE BUT IT WAS POSSIBLE TO DRILL. WHEN THE DRILL WAS BEING REMOVED, THE TIP CAME LOOSE AND GOT STUCK IN THE TUNNEL, BUT IT WAS COMPLETELY REMOVED WITH THE HELP OF KELLY TWEEZERS WITHOUT HARMING THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486604 ↗
• InjuryJan 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN DRILLING THE FEMUR BONE WITH THE FLEXIBLE DRILL, THE DEVICE'S 4.5 BIT BROKE. EXCESSIVE FORCE WAS NOT APPLIED AND THE DRILL WAS NOT ROTATED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131824 ↗
• MalfunctionJul 11, 2022Break; Break

  IT WAS REPORTED THAT THE FLEXIBLE DRILL WAS FOUND BROKEN INSIDE THE TRAY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982008 ↗
• InjuryJul 8, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, WHEN DRILLING THE CORTEX OF THE FEMUR WITH THE 4.5MM FLEXIBLE DRILL, IT SPLIT AND IT HAD TO BE DRILLED WITH THE AUGER 5.0MM FROM THE OUTSIDE TO THE INSIDE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14956346 ↗
• MalfunctionMar 14, 2022Crack; Crack

  IT WAS REPORTED THAT AFTER AN ACL FEMUR REPAIR PROCEDURE WHERE THE DRILL BIT WAS USED TO TUNNEL INTO THE FEMUR, IT WAS FOUND TO BE CRACKED. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759570 ↗
• InjurySep 23, 2021Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, INSIDE THE PATIENT, USING DRILL FLEXIBLE ENDOSCOPIC CANN 4.5MM AT THE TIME OF MAKING THE FEMUR TUNNEL, THE DOCTOR PRESSED THE REVERSE DRILL BUTTON AND THE DRILL BROKE INSIDE THE PATIENT. A PIECE IN THE JOINT, WASN'T REMOVED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12523105 ↗
• MalfunctionJun 25, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE SIZING ETCHINGS ON THE CLANCY FLEXIBLE REAMERS WARN OFF- IT WAS NOT ABLE SEE THE DEPTH MEASUREMENT UNDER SCOPE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071566 ↗
• InjuryJun 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE FEMORAL TUNNEL WAS BEING DRILLED WITH THE FLEXIBLE CLANCY DRILL AND HALF WAY UP THE FEMUR, THE TIP OF THE DRILL BIT COMPLETELY SNAPPED OFF AND IT STARTED TO UNRAVEL ALL THE WAY THROUGH THE DRILL. THIS HAPPENED WHEN IT WAS ON THE FORWARD POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964891 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT THE DRILL FLEXIBLE ENDOSCOPY WAS BROKEN. INCIDENT OCCURRED WHILE SETTING-UP TO A KNEE ACL. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OCCURRED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781549 ↗
• InjuryMar 11, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, AT THE MOMENT OF FEMORAL PERFORATION, THE DRILL FLEXIBLE ENDOSCOPIC CANNULA BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11461986 ↗
• InjuryAug 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF FLEXIBLE REAMER BROKE OFF DURING ACL PROCEDURE, THE REAMING HAD ALREADY BEEN COMPLETED BOTH THE SHAFT AND THE TIP OF THE FLEXIBLE REAMER WERE RECOVERED WITH GRASPER. THERE WAS NO DELAY OR FURTHER 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 10440115 ↗
• MalfunctionJun 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY, THE DRILL FLEXIBLE WAS REMOVED AND THE BIT WAS FOUND TO BE BROKEN ON ONE SIDE. THE AUGER DID NOT LEAVE ANY SCRAP OF METAL INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. NO 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: Injury

  MAUDE report 10185911 ↗