CLANCY 72203164Recalls & reported problems
Smith & Nephew, Inc. · CLANCY 8.5 MM FLEXIBLE DRILL · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010654571), received between Nov 15, 2018 and Oct 5, 2023 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Appropriate Device Problem Term/Code Not Available1
- Stretched1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2023Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CLANCY FLEXIBLE DRILL BROKE WHEN USING IT; HOWEVER THE PIECES WERE TRAPPED IN THE DEVICE GUIDE, A HEMOSTAT WAS USED TO TRAP THEM AND REMOVE THEM FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17877367 ↗InjuryMay 23, 2022Break; Break
IT WAS REPORTED THAT DURING USE IN AN ACL RECONSTRUCTION, THE DRILL FLEXIBLE BREAK IN THE PATIENT. ALL THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT BY PUTTING THE 4.5MM REAMER OVER THE GUIDE WIRE AND MALTING THE HEAD OF THE BROKEN DRILL BIT BACK INTO THE JOINT AND WAS THEN RETRIEVED THE BROKEN PIECE WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14470287 ↗MalfunctionDec 22, 2018Stretched
IT WAS REPORTED THAT SA WAS DRILLING FEMORAL TUNNEL. SHE HAD JUST ENTERED THE FEMORAL TUNNEL IN FORWARD FULL SPEED AND WAS MOVING THE DRILL SLOWLY. SHE STOPPED DRILL TO READ THE DEPTH OFF OF REAMER. THE SURGEON NOTICED THAT THE DISTAL TIP OF REAMER BETWEEN TIP AND FLEXIBLE SHAFT WAS BEING STRETCHED. THE SURGEON COMMENTED, "ONCE YOU START TO DRILL, ITS GOING TO SNAP AGAIN." AND, THAT'S EXACTLY WHAT HAPPENED. THIS IS THE SECOND FLEXIBLE REAMER TO SNAP IN PAST SIX WEEKS. WE WENT THROUGH ALL CHECKPOINTS OF POSSIBLE REASONS FOR THIS AND CONCLUDED IT HAD TO BE AN ISSUE WITH THE REAMER. THE REAMER HAS ONLY BEEN USED LESS THAN 5 TIMES. A KELLY WAS USED TO REMOVE PIECES AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8193056 ↗MalfunctionDec 12, 2018Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT SA WAS DRILLING FEMORAL TUNNEL. SHE HAD JUST ENTERED THE FEMORAL TUNNEL IN FORWARD FULL SPEED AND WAS MOVING THE DRILL SLOWLY. SHE STOPPED DRILL TO READ THE DEPTH OFF OF REAMER. THE SURGEON NOTICED THAT THE DISTAL TIP OF REAMER BETWEEN TIP AND FLEXIBLE SHAFT WAS BEING STRETCHED. THE SURGEON COMMENTED, "ONCE YOU START TO DRILL, ITS GOING TO SNAP AGAIN." AND, THAT'S EXACTLY WHAT HAPPENED. THIS IS THE SECOND FLEXIBLE REAMER TO SNAP IN PAST SIX WEEKS. WE WENT THROUGH ALL CHECKPOINTS OF POSSIBLE REASONS FOR THIS AND CONCLUDED IT HAD TO BE AN ISSUE WITH THE REAMER. THE REAMER HAS ONLY BEEN USED LESS THAN 5 TIMES. A KELLY WAS USED TO REMOVE PIECES AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8156950 ↗MalfunctionNov 15, 2018Break
IT WAS REPORTED THAT DRILL BIT SNAPPED IN HALF AS SURGEON WAS DRILLING TUNNEL, IT BROKE IN 2 PIECES. BROKEN PIECES WERE REMOVED FROM THE PATIENT. NO BACK UP DEVICE WAS AVAILABLE. THERE WAS NO DELAY OR PATIENT INJURIES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8075407 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.