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CLANCY 72203165Recalls & reported problems

Smith & Nephew, Inc. · CLANCY 9.5 MM FLEXIBLE DRILL · Class 1

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010654588), received between Nov 12, 2018 and Apr 18, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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: 1 reportsMay 2024: 0 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

  • Break2
  • Device Markings/Labelling Problem1
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 18, 2024Break; Break

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CANNULATED FLEXIBLE DRILL FELT USED AND DID NOT HAVE THE LENGTH MARK NUMBERS ANY LONGER; THE DRILL BROKE INSIDE THE PATIENT, ALL THE PIECES WERE REMOVED WITH A PASSING PIN AND PITUITARY. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19131510 ↗
  • 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 12071694 ↗
  • MalfunctionMar 9, 2020Material Separation; Material Separation

    IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE 9.5 MM CLANCY FLEXIBLE DRILL BROKE WHEN ATTEMPTING TO DRILL THE FEMORAL TUNNEL. ALL FRAGMENTS WERE REMOVED: A KELLY CLAMP AND PAIR OF PLIERS WERE USED TO REMOVE THE BROKEN PART. A BACK-UP DEVICE WAS USED TO PERFORM THE TUNNEL IN THE SAME LOCATION. THE SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED. 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 9806239 ↗
  • MalfunctionNov 12, 2018Break

    IT WAS REPORTED THAT THE SURGEON DRILLED THE FEM TUNNEL TO APPROPRIATE LENGTH AND PROCEEDED TO KEEP DRILL IN FORWARD AND BACK OUT THE TUNNEL. THE DRILL WAS MOVING OUT SMOOTHLY WITH NO TORQUING ON BIT. A FEW MILLIMETERS BEFORE TUNNEL APERTURE, THE DISTAL TIP OF REAMER BETWEEN TIP AND FLEXIBLE SHAFT SNAPPED IN 2 PIECES. (B)(6) WAS USED TO PULL AND DISLODGE BOTH PIECES, DELAYING CASE BY SEVERAL MINUTES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8061232 ↗

Other ACCESSORIES,ARTHROSCOPIC devices

All ACCESSORIES,ARTHROSCOPIC devices →

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