CLANCY 7209737Recalls & reported problems
Smith & Nephew, Inc. · CLANCY 8 MM FLEXIBLE DRILL · Class 1
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010541987), received between Dec 4, 2017 and May 7, 2024 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Device Markings/Labelling Problem2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient3
- No Code Available1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 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 19264724 ↗MalfunctionOct 17, 2023Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN THE DRILL BIT DRILLED THE BONE, IT WAS VERY HARD AND THE DRILL BIT BROKE. ALL THE DRILL BIT PIECES WERE REMOVED WITH AN HEMOSTAT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17952540 ↗InjuryJul 27, 2022Break; Break
IT WAS REPORTED THAT, DURING A ACL RECONSTRUCTION/KNEE PROCEDURE, WHEN THE FLEXIBLE DRILL STARTED BEING USED AND ENTERING THE TUNNEL, IT STOPPED TURNING. THE DRILL WAS TAKEN OUT AND IT WAS NOTICED THAT IT WAS BROKEN. ALL PIECES WERE REMOVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS STABLE AND IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15112762 ↗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 12071626 ↗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 12071588 ↗MalfunctionDec 12, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN ACL CASE DRILL BROKE WHILE DRILLING THROUGH FEMUR. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY 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 9458981 ↗MalfunctionJul 3, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING THE SURGERY THE DEVICE BROKE IN HALF IN THE MIDDLE OF A CASE. NO DELAY OR PATIENT INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8759565 ↗MalfunctionAug 6, 2018Break
IT WAS REPORTED THAT THE DRILL BIT HEAD BROKE OFF IN THE PATIENT'S FEMUR DURING AN ACL. THE FEMUR WAS EXTREMELY HARD BONE IN A YOUNG PATIENT AND BROKE OFF WHILE BACKING THE DRILL OUT OF THE FEMORAL SOCKET. THE SURGEON THOUGHT HE WAS DRILLING OUT IN FORWARD. THE DRILL BIT HEAD THAT BROKE OFF WAS A CLEAN BREAK/SINGLE PIECE THAT WAS RETRIEVED OUT OF THE PATIENT WITH 5 MIN DELAY. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Code Available
MAUDE report 7754410 ↗MalfunctionDec 4, 2017Break
IT WAS REPORTED THAT THE DEVICE REAMER BROKE WHEN IT CONTACTED THE BONE. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7079566 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.