CLANCY 7209739Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010541970), received between Jul 18, 2017 and Sep 9, 2024 — classified as 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (14 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE HEAD OF A 10 MM DRILL FLEXIBLE ENDOSCOPIC CANNULA BROKE OFF WHILE DRILLING AN ACL TUNNEL. THE BROKEN DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS FINISHED WITH A 9.5 MM SMITH AND NEPHEW DRILL BACKUP DEVICE. THERE WAS A 4 MINUTES SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169457 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, TWO (2) FLEXIBLE FEMORAL DRILLS FELT SOFT, LIKE THEY WERE GOING TO BREAK, AT THE MOMENT OF USE, BOTH DRILLS BROKE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING A PITUITARY GRASPER. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607767 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, THE SURGEON FELT LIKE A DRILL FLEXIBLE ENDOSCOPIC CANNULA WAS GOING TO BREAK; AFTER HE DRILLED, IN FACT THE DEVICE BROKE IN HALF. A BACK-UP DEVICE WAS OPENED AND THE SAME ISSUE HAPPENED WITH A SECOND DRILL FLEXIBLE. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH A PITUITARY. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY OF LESS THAN 30 MINUTES WITH THE THIRD OPENED DEVICE, NO VOIDS WERE LEFT IN THE PATIENT WHOSE BONE QUALITY WAS HEALTHY AND HIS HEALTH WAS NOT AFFECTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395370 ↗
• InjurySep 19, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, WHEN THE DRILLING IN THE FEMORAL TUNNEL BEGAN, THE 10MM FLEXIBLE DRILL DEVICE BROKE. IT IS UNKNOWN WHETHER IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451852 ↗
• InjuryMar 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, THE ENDOSCOPIC DRILL BROKE UP. ALL PIECES WERE REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938746 ↗
• InjuryDec 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN LEFT KNEE ACL RECONSTRUCTION, THE 10 MM DRILL FLEXIBLE BROKE INTO SEVERAL PIECES WHILE MAKING THE FEMORAL TUNNEL. ALL PIECES WERE REMOVED FROM THE PATIENT. FLUOROSCOPY WAS USED TO ENSURE THAT NO PIECES REMAINED IN THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF A DELAY OCCURRED. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043856 ↗
• InjuryJun 18, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE 10MM FLEXIBLE DRILL BROKE OFF WHILE DRILLING THE FEMUR. A SUDDEN CURVE OF THE GUIDE PIN WAS NOTICED BEFORE DRILLING WHERE IT MET THE LATERAL FEMORAL CONDYLE, WHICH MAY HAVE CAUSED THE DRILL TO BREAK. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY (3 MINUTES) USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026303 ↗
• InjuryMay 8, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE FLEXIBLE REAMER WAS USED TO DRILL FEMORAL TUNNEL, UPON ADVANCING THE REAMER, IT BROKE IN HALF WITH HALF IN THE LEG AND HALF OUT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAY AND NO PATIENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11795320 ↗
• MalfunctionMar 13, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WERE METAL PIECES IN THE SHAFT OF THE DRILL FLEXIBLE ENDOSCOPIC CANN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478606 ↗
• MalfunctionMar 10, 2021Flaked; Flaked

  IT WAS REPORTED THAT THERE ARE METAL PIECES IN THE SHAFT OF THE DRILL FLEXIBLE ENDOSCOPIC CANN 10MM. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456982 ↗
• MalfunctionMar 10, 2021Flaked; Flaked

  IT WAS REPORTED THAT THERE ARE METAL PIECES IN THE SHAFT OF THE DRILL FLEXIBLE ENDOSCOPIC CANN 10MM. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456938 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, THE FLEXIBLE DRILL BROKE IN HALF WHILE IN USE. THE PROCEDURE WAS COMPLETED WITHOUT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10934676 ↗
• InjurySep 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING SURGERY, THE "10MM CLANCY FLEXIBLE DRILL" BROKE. THE PHYSICIAN REMOVED THE BROKEN PIECE FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING ANOTHER S+N 10MM CLANCY FLEXIBLE DRILL. NO 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 Information

  MAUDE report 10607509 ↗
• InjurySep 3, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE FLEXIBLE DRIL BROKE, ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY WAS 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 10489303 ↗
• MalfunctionFeb 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE 10MM CLANCY FLEXIBLE DRILL BROKE INSIDE THE PATIENT. BROKEN PIECES WERE REMOVED WITH TWEEZERS. THEN SURGEON REPEATED THE SAME TECHNIQUE WITH A NEW PIN AND REAMER THROUGH A SLIGHTLY DIFFERENT PORTAL AND IT WENT PERFECTLY FROM THERE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY AND NO PATIENT INJURIES 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 9720103 ↗
• MalfunctionMay 17, 2019Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE HEAD OF THE 10.0 MM CLANCY FLEXIBLE DRILL BROKE OFF IN THE FEMUR WHEN DRILLING. THE PIECE WAS RETRIEVED FROM THE BONE USING A GRASPER. A 9.5 MM BACK-UP DEVICE WAS USED TO DRILL THE SAME TUNNEL TO FINISH THE CASE. THE SURGERY WAS DELAYED LESS THAN 10 MINUTES. THE PATIENT DID NOT EXPERIENCE ANY KIND OF DAMAGE.

  Patient problems: No Code Available

  MAUDE report 8619951 ↗
• MalfunctionApr 3, 2019Break

  IT WAS REPORTED THAT DURING A ACL SURGERY THE DRILL BIT BROKE IN HALF WHILE REAMING IN THE FEMORAL TUNNEL, ALL THE PIECES WERE REMOVED FROM THE PATIENT. THERE WAS A SIGNIFICANT DELAY IN THE PROCEDURE BUT NO PATIENT INJURIES WERE REPORTED, THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8479062 ↗
• MalfunctionNov 14, 2018Break

  IT WAS REPORTED THAT THE DEVICE BROKE INSIDE THE PATIENT, HOWEVER, ALL PIECES WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED. BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8070804 ↗
• MalfunctionSep 6, 2017Split

  IT WAS REPORTED THAT DEVICE SPLIT DURING DRILLING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6844518 ↗
• MalfunctionJul 18, 2017Break

  IT WAS REPORTED THAT THE FLEXIBLE DRILL REAMER BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY WITHOUT PATIENT IMPACT FOLLOWING A SHORT DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6723544 ↗