CLANCY 7209738Recalls & reported problems
Smith & Nephew, Inc. · CLANCY 9 MM FLEXIBLE DRILL · Class 1
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010541994), received between Dec 28, 2017 and Mar 10, 2025 — classified as 4 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Break” (9 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.
Reports received per month
Most reported problems
Device problems
- Break9
- Device Markings/Labelling Problem5
- Material Separation2
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient8
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2025Break; Break
IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE CLANCY REAMER BROKE MID-BODY WHILE DRILLING A FEMORAL TUNNEL. TWO PIECES WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT, AS THEY WERE CONNECTED TO A GUIDE PIN THROUGH THE REAMER¿S CANNULATION, GRASPER, AND PICKUPS. THE PROCEDURE WAS COMPLETED USING AN S+N BACKUP 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 21566350 ↗MalfunctionJul 5, 2024Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FLEXIBLE ENDOSCOPIC DRILL BROKE IN TWO PARTS DURING DRILLING THE FEMUR. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A BACK-UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679916 ↗InjuryAug 25, 2022Break; Break
IT WAS REPORTED THAT DURING THE USE OF THE DRILL FLEXIBLE ENDOSCOPIC, ITS DRILL WAS BROKEN. BROKEN PART COULD BE RETRIEVED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW 8.5MM FLEX DRILL. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15299213 ↗InjuryJun 28, 2022Break; Break
IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, FEMORAL WHEN DRILLING BEGAN IN THE FEMUR, THE FLEXIBLE DRILL CANNULA BROKE. THE DRILL BIT WAS PLACED INSIDE THE 2.4MM GUIDE, SO IT IS DRILLED FROM THE OUTSIDE IN WITH THE 4.5MM BIT, AND THIS PUSHES THE BROKEN BIT, THEN THE DOCTOR FINISHES REMOVING IT WITH A HEMOSTAT. TO FINISH THE PROCEDURE THE 8.5MM FLEXIBLE AUGER WAS USED, FROM THE SAME CLANCY SYSTEM. NON-SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14840935 ↗InjuryMar 22, 2022Break; Break
IT WAS REPORTED THAT, DURING AN ACL SURGERY IN THE FEMORAL CODYLE AREA, WHEN STARTING TO REAM THE FEMUR TUNNEL, THE DRILL FLEXIBLE ENDOSCOPIC BROKE OFF. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING AN AUGER ENTERING 4.5MM FROM THE OUTSIDE IN, PUSHING THE PIECE OF THE AUGER 9.0MM. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE (DRILL 8.5MM FLEXIBLE FEMUR). NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13852686 ↗InjuryDec 20, 2021Break; Break
IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN DRILLING THE FEMORAL TUNNEL, THE REAMER WAS REMOVED FROM THE KNEE AND THEN REALIZED THAT THE ACORN REAMER END HAD BROKEN OFF WHILE DRILLING. THE REAMER PART HAD BROKEN AT A FLEXIBLE COIL AND THE ENTIRE HEAD OF THE DRILL WAS STILL IN THE TUNNEL; THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH A SNAP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING THE SAME DEVICE AS THE DRILLING WAS DONE ONCE THE REAMER BROKE . NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13044220 ↗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 REAMER 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 12071650 ↗MalfunctionOct 17, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING FEMORAL REAMING, NO MEASUREMENTS WERE VISIBLE IN THE FLEXIBLE 9MM CANNULA. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR 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: No Known Impact Or Consequence To Patient
MAUDE report 10694669 ↗MalfunctionOct 17, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING FEMORAL REAMING, NO MEASUREMENTS WERE VISIBLE IN THE FLEXIBLE 9MM CANNULA. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR 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: No Known Impact Or Consequence To Patient
MAUDE report 10694666 ↗MalfunctionOct 17, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING FEMORAL REAMING, NO MEASUREMENTS WERE VISIBLE IN THE FLEXIBLE 9MM CANNULA. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR 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: No Known Impact Or Consequence To Patient
MAUDE report 10694662 ↗MalfunctionOct 17, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING FEMORAL REAMING, NO MEASUREMENTS WERE VISIBLE IN THE FLEXIBLE 9MM CANNULA. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR 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: No Known Impact Or Consequence To Patient
MAUDE report 10694660 ↗MalfunctionFeb 4, 2020Material Separation; Material Separation
IT WAS REPORTED ABOUT A 9 MM FLEXIBLE DRILL THAT, DURING AN UNKNOWN PROCEDURE, BROKE WHILE DRILLING THE FEMORAL TUNNEL. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE OR IF THERE WAS A DELAY IN THE SCHEDULED SURGERY. NO PATIENT INJURIES OR 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: No Known Impact Or Consequence To Patient
MAUDE report 9664249 ↗MalfunctionNov 10, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING CASE THE CLANCY REAMER BROKE IN THE BONE TUNNEL, IT WAS REMOVED AND USE BACK UP SET TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR DELAY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9302683 ↗MalfunctionJul 10, 2018Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING ACL RECONSTRUCTION THE TIP BROKE OFF ON THE 9MM FLEXIBLE DRILL. NO PATIENT HARM OR INJURY. THERE WAS A 10 MIN DELAY, CASE WAS COMPLETED WITH A BACKUP DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7675187 ↗MalfunctionJan 25, 2018Break
IT WAS REPORTED THAT THE TIP OF THE DRILL BIT BROKE OFF IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7220644 ↗MalfunctionDec 28, 2017Break
IT WAS REPORTED THAT THE TIP OF THE DRILL BIT BROKE OFF IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7153312 ↗
Other BIT, DRILL devices
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- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.