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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

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: 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

  • 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 ↗

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.