CLANCY 72202972Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010654533), received between Sep 6, 2017 and Sep 22, 2022 — classified as 3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY A TUNNEL WAS MADE WITH THE DRILL FLEXIBLE ENDOSCOPIC CANN, HOWEVER THE SPECIALIST DID NOT LIKE THE POSITION VERY MUCH, AND DID A SECOND TUNNEL, WHERE THE DRILL BROKE. AT THE END, THE DOCTOR STUCK WITH THE FIRST TUNNEL OPTION, THE BROKEN PARTS OF THE DRILL WERE COMPLETELY REMOVED. NO DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation; Rupture

  MAUDE report 15462925 ↗
• InjuryJul 19, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHEN MAKING THE FEMORAL TUNNEL, THE 2.4 DRILL WAS USED AND WHEN PASSING THE 5-0 MM DRILL, IT BROKE IN THE TUNNEL. THE TIP OF THE DRILL WAS COMPLETELY REMOVED WITH THE HELP OF KELLY FORCEPS. SURGERY WAS RESUMED, WITHOUT SURGICAL DELAY, WITH A BACK-UP DEVICE. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058891 ↗
• MalfunctionNov 11, 2021Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT, DURING SET UP, THE DRILL FLEXIBLE ENDOSCPC CANN 5MM WAS DAMAGED. THE MALFUNCTION WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING A BACK UP DEVICE. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE SHAFT OF THE DEVICE IS FRACTURED IN MULTIPLE PLACES THROUGHOUT WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800179 ↗
• InjuryMay 14, 2021Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BIT OF THE DRILL THAT BROKE WAS ON THE WIRE GUIDE AND WHEN REMOVING, IT CAME ALONG WITH THE WIRE. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO SIGNIFICANT DELAY AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826950 ↗
• MalfunctionSep 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE FLEXIBLE REAMER BROKE INSIDE THE PATIENT WHILE REAMING FOR THE ENDOBUTTON TUNNEL, ALL THE BROKEN PIECES WERE REMOVED USING HEMOSTAT. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962524 ↗
• MalfunctionMay 24, 2019Break

  IT WAS REPORTED THAT WHEN PASSING THE FLEXIBLE DRILL BIT, IT BROKE INSIDE THE PATIENT. NO SIGNIFICANT DELAY WAS REPORTED. IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE. THE PIECES WERE REMOVED FROM THE PATIENT AND THERE WERE NO INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8640366 ↗
• MalfunctionMay 21, 2019Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, THE DRILL BROKE IN THE MIDDLE WHILE PIERCING THE PATIENT'S FEMUR. A BACK UP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8628389 ↗
• MalfunctionDec 24, 2018Break

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE BROKE WHEN IT WAS MILLING WITH THE DRILL. IT IS UNKNOWN IF THE PIECES WERE RETRIEVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8194077 ↗
• MalfunctionOct 20, 2018Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE DRILL BROKE IN THE PATIENT'S FEMUR. BROKEN PIECES WERE REMOVED FROM THE PATIENT. NO SURGICAL DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7988274 ↗
• MalfunctionNov 15, 2017Break

  IT WAS REPORTED THAT AT THE MOMENT OF STARING THE FEMORAL TUNNEL, THE DRILL BIT WAS BROKEN AND THE PIECE WAS REMOVED WITH A CLAMP. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7034852 ↗
• MalfunctionOct 5, 2017Break

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE TIME OF INTRODUCING THE DRILL FLEXIBLE DEVICE TO START DRILLING, THE PRODUCT BROKE. THE INCIDENT HAPPENED INSIDE THE PATIENT, HOWEVER THE DEVICE WAS REMOVED. THE PATIENT´S HEALTH CONDITION IS STABLE AND NO DAMAGE WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915219 ↗
• MalfunctionSep 6, 2017Break

  IT WAS REPORTED DRILL BROKE WHEN PREPARING THE BONE TUNNEL. BROKEN PIECES WERE REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. DELAY WAS LESS THAN 30 MINUTES AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6846835 ↗