NA 7207315Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 03596010425409), received between Apr 26, 2017 and Apr 1, 2026 — classified as 29 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT DURING AN ACL KNEE ARTHROSCOPY, WHILE PERFORMING A TIBIA TUNNEL, ONE (1) 4.5 CANNULATED DRILL BROKE IN HALF. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. FLUOROSCOPY WAS PERFORMED TO CHECK FOR METALLIC TRACES AND WAS CONFIRMED THAT NOTHING WAS LEFT IN THE JOINT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE, THE TUNNEL WAS DRILLED BEFORE THE DEVICE BROKE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752521 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH ACL AND MENISCAL SUTURE, WHILE REAMING THE TIBIA ONE (1) CANNULATED DRILL BIT BROKE. THE BROKEN INSTRUMENT WAS COMPLETELY REMOVED FROM THE PATIENT. 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 24699782 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE SURGEON WAS PREPARING THE FEMORAL TUNNEL. THE SURGEON FIRST DRILLED WITH THE 2.4 DRILL BIT, AND WHEN SWITCHING TO THE 4.5 DRILL BIT, THE ENDOSCOPIC CANNULA DRILL BROKE INSIDE THE PATIENT¿S FEMORAL TUNNEL APPROXIMATELY 20 MM. THE BROKEN TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A DELAY OF LESS THAN 30 MINUTES, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414260 ↗
• MalfunctionSep 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, WHILE DRILLING WITH THE 2.4 PASSING PIN INSIDE THE CANNULATION OF THE 4.5 ENDOSCOPIC DRILL TO ENSURE THE CANNULATION WAS NOT HOLLOW, THE ENDOSCPC CANN.DRL.BIT 4.5 STRL TIP BROKE; THE SURGEON REMOVED ALL BROKEN PIECES FROM THE PATIENT¿S KNEE, AND THE PROCEDURE WAS RESUMED AFTER A NON SIGNIFICANT SURGICAL DELAY USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23164228 ↗
• MalfunctionMay 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, UPON OPENING A STERILE ENDOSCOPIC CANNULA DRILL BIT, THE STERILE WRAP INSIDE THE BOX WAS FOUND UNSEALED AND THEREFORE COULD NOT BE USED IN SURGERY. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068116 ↗
• InjuryFeb 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ENDOSCOPIC CANNULATED DRILL BIT TIP BROKE OFF WHILE DRILLING THE FEMORAL TUNNEL AND GOT STUCK IN THE TUNNEL. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT, THE SURGEON HAD TO PUSH THE BROKEN TIP BY DRILLING BEHIND IT. HE THEN MADE AN ADDITIONAL INCISION ON THE THIGH OF THE PATIENT TO PULL THE BROKEN TIP OUT WITH FORCEPS. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339963 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN DRILLING A BONE HOLE IN THE FEMUR, THE TIP OF THE ENDOSCOPIC CANNULATED DRILL AND THE PART WITH THE SCALE BROKE OFF. THE TIP SPLIT VERTICALLY INTO THREE PIECES INSIDE THE BONE HOLE, AND ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING FORCEPS. SURGERY WAS COMPLETED WITH THE SAME DEVICE AFTER RE-STERILIZATION. A SURGICAL DELAY OF 2 HOURS OCCURRED, BUT NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335019 ↗
• MalfunctionMay 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ACL AND MENISCUS REPAIR, THE GUIDE WAS PASSED AND THE TUNNEL WAS DRILLED WITH THE CANNULATED DRILL BIT, WHICH DID NOT PASS EASILY BECAUSE IT WAS COLLIDING WITH THE GUIDE, CAUSING DAMAGE TO THE DRILL BIT. THE TUNNEL COULD NOT BE PREPARED TO PASS THE ULTRABUTTON. THE SPECIALIST REMOVED THE GUIDE, IT WAS BENT, SO THE TECHNIQUE WAS CHANGED WITH BIOSURE RG, THE IMPLANT ALREADY PREPARED IN THE GRAFT WAS REMOVED AND THE TECHNIQUE WITH THE INTERFERENCE SCREW WAS USED. THE PROCEDURE WAS COMPLETED WITH A DELAY OF HOURS USING A INTERFERENCE SCREW TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336723 ↗
• MalfunctionApr 17, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CANNULA ENDOSCOPE DRILL WAS DAMAGED AND BROKE INSIDE THE PATIENT; ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122956 ↗
• MalfunctionNov 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE ENDOSCOPIC DRILL WAS BENT AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SIGNIFICANT SURGICAL DELAY GREATER THAN 30 MIN AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136173 ↗
• InjuryJul 25, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, AN ENDOSCOPIC CANNULATED DRILL BIT SNAPPED IN HALF WHILE DRILLING A PASSAGE TO PASS AN ACL GRAFT. THE PROCEDURE COULD BE COMPLETED WITH THE SAME DEVICE. THE TWO HALVES WERE REMOVED BY THE SURGEON AND AN X RAY WAS OBTAINED SHOWING FRAGMENTS OF METAL IN THE BONE. A NON-SIGNIFICANT DELAY WAS REPORTED. NO HARM TO DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17393564 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ENDOSCPC CANN.DRL.BIT 4.5 STRL BROKE, ALL THE BROKEN PIECES WERE REMOVED WITH A GRASPER. 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 17022254 ↗
• InjuryApr 11, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ACL TUNNEL PROCEDURE, THE TIP OF THE ENDOSCOPIC CANNULA DRILL BIT BLEW OFF IN THE PATIENT. THE TIP WAS REMOVED WITH GRASPERS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715695 ↗
• MalfunctionFeb 16, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ACL KNEE ARTHROSCOPY AND MENISCUS REPAIR, THE SPECIALIST DECIDED TO PERFORM A SUSPENSION METHOD USING THE ULTRABUTTON FIXATION DEVICE. WHEN TRYING TO DRILL THE TUNNEL USING THE ENDOSCOPIC CANNULATED DRILL BIT OF SUSPENSION, THE DRILL BIT DID NOT GO THROUGH; SINCE IT COLLIDED WITH THE GUIDE. THE DRILL BIT GOT DAMAGED IN THE PROCESS; THEREFORE, THE TUNNEL TO INSERT THE ULTRABUTTON FIXATION DEVICE COULDN'T BE PREPARED. THE SPECIALIST REMOVED THE GUIDE AND NOTICED IT WAS BENT. IT WAS RECOMMENDED TO CHANGE TO ANOTHER DRILL BIT IN ORDER TO DRILL THE TUNNEL, BUT THE SPECIALIST DECIDED TO PERFORM ANOTHER TECHNIQUE USING THE BIOSURE REGENESORB INTERFERENCE SCREW. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390606 ↗
• InjuryDec 26, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, THE CANNULATED DRILL BROKE AND A TINY PIECE WAS LEFT IN SITU. BROKEN PIECES WERE REMOVED USING SUCTION. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT WAS REVIEWED POST OPERATIVELY AND HE WAS IN GOOD HEALTH.

  Patient problems: Foreign Body In Patient

  MAUDE report 16048838 ↗
• InjuryDec 26, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE ENDOSCOPE DRILL BROKE WHEN THE DOCTOR STARTED DRILLING INTO THE FEMORAL TUNNEL. THE BROKEN PIECES OF THE DRILL WERE REMOVED WITH THE HELP OF A GRASPER. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO ADDITIONAL BONE HOLE WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16047835 ↗
• InjuryDec 13, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ENDOSCOPE DRILL BROKE, ALL DEBRIS WAS REMOVED FROM THE PATIENT WITH A PITUITARY RONGEUR. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969187 ↗
• MalfunctionSep 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A 5.0MM CANNULATED DRILL BIT (B)(4) AND A 4.5MM CANNULATED DRILL BIT (B)(4) WERE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397984 ↗
• InjuryJul 26, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE CANNULATED DRILL BIT SNAPPED IN THE FEMORAL TUNNEL OPENING. THE ISSUE AROSE WHEN THE GUIDE WIRE AND THE REPORTED DEVICE BENT WHILST DRILLING. ALL THE PIECES WERE REMOVED AND THE TUNNEL WAS RE-DRILLED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 15104129 ↗
• InjuryJul 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, WHEN THE SURGEON WENT TO DRILL THE ENDOSCOPIC DRILL OVER THE LONG DRILL TIP PASSING PIN, SHARDS OF METAL CAME LOOSE FROM THE ENDOSCOPIC DRILL AND FELL INTO THE PATIENT. THE BROKEN PIECES WERE REMOVED BY SUCTION. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977611 ↗
• InjuryMar 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE 'ENDOSCOPIC CANNULATED DRILL BIT' BLEW OFF IN THE PATIENT AND HAD TO BE REMOVED SEPARATELY. THE PIECES WERE REMOVED WITH GRASPER AND USING SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. A DELAY GREATER THAN 30MIN TOOK PLACE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866097 ↗
• InjuryMar 22, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHILE USING THE ENDOSCOPIC CANN DRILL BIT IT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DISTAL TIP OF THE DRILL BIT IS BROKEN FROM THE SHAFT WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13853244 ↗
• MalfunctionMar 22, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, THE TIP OF THE 'ENDOSCOPIC CANNULATED DRILL BIT' CRACKED, BUT IT DID NOT BREAK INTO PIECES. THUS, NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847294 ↗
• InjuryMar 10, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE TIP OF THE DRILL BROKE UPON INSERTION. THE TIP WAS REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13717790 ↗
• InjuryMar 8, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE TIP OF THE DRILL BIT BROKE OFF. ALL PIECES HAVE BEEN REMOVED FROM THE PATIENT BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. THE SAME BONE HOLE WAS USED. NON-SIGNIFICANT DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690603 ↗