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CLANCY 7209008Recalls & reported problems

Smith & Nephew, Inc. · 7 MM CLANCY FLEXIBLE DRILL · Class 1

Adverse event reports
8
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010601445), received between Feb 13, 2020 and May 8, 2024 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (7 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: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 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

  • Break7
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 8, 2024Break; Break

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AS THE PHYSICIAN BEGAN TO DRILL THE FEMUR TUNNEL, THE FLEXIBLE DRILL BROKE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19274734 ↗
  • InjuryJan 11, 2023Break; Break

    IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, WHEN DRILLING INTO THE FEMUR THE BIT OF THE FELXIBLE DRILL BROKE. ALL PIECES WERE REMOVED WITH SUCTION AND WITH HEMOSTATIC FORCEPS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16137993 ↗
  • MalfunctionDec 6, 2022Break; Break

    IT WAS REPORTED THAT, DURING SET UP, THE AUGER OF THE CLANCY FLEXIBLE DRILL, 7.0 MM WAS FOUND FRACTURED/SPLIT INSIDE THE TRAY. NO DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15925588 ↗
  • InjuryJun 27, 2022Break; Break

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, WHEN DRILLING THE FEMUR WITH THE DRILL FLEXIBLE ENDOSCOPIC CANN, THE DRILL BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OF IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14836177 ↗
  • InjuryJun 9, 2022Break; Break

    IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, WHEN THE FEMORAL TUNNEL WAS MADE, THE DRILL BROKE. 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 14640526 ↗
  • InjuryJul 7, 2021Break; Break

    IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT, WHEN THEY STARTED TO DRILL IN THE FEMUR, THE 7MM FLEXIBLE BIT BROKE. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12129861 ↗
  • InjurySep 20, 2020Break; Break

    IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE DOCTOR STARTED TO MAKE THE FEMORAL TUNNEL, THE BIT BROKE INSIDE THE PATIENT WHEN IT HAD ONLY ENTERED 10MM. IT IS UNKNOWN IF THERE WAS A DELAY OR BACK UP WAS AVAILABLE TO COMPLETE 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: No Information

    MAUDE report 10558151 ↗
  • MalfunctionFeb 13, 2020Material Separation; Material Separation

    IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE 7MM FLEXIBLE DRILL BROKE WHILE BEGINNING TO DRILL THE 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 9708498 ↗

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.