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