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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

All BIT, DRILL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.