NA 214116Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705003570), received between Dec 5, 2017 and Jan 7, 2026 — 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHEN THE SURGEON INSERTED THE CLEARCANNULA-THREADED 7.0MMX75MM DEVICE INTO THE BODY, THE TIP OF THE DEVICE CHIPPED OFF AND BROKE, AND FRAGMENTS OF THE DEVICE FELL INTO THE JOINT. IT WAS REPORTED THAT THE FRAGMENTS WERE RETRIEVED AND BECAUSE THEY ARE NOT MADE OF MATERIAL THAT SHOWS UP ON X-RAYS, IT WAS CONFIRMED THAT THE SHAPE OF THE BROKEN BODY AND THE FRAGMENTS MATCHED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS 30-MINUTE SURGICAL DELAY DUE TO THE EVENT. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991469 ↗
• MalfunctionJun 23, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) PROCEDURE, WHEN THE SURGEON INSERTED THE ANCHOR DEVICE THROUGH THE CLEARCANNULA-THREADED 7.0MMX75MM CANNULA DEVICE, THE MIDDLE LAYER OF THE THREE-LAYER SEAL WAS DAMAGED, CAUSING THE ANCHOR TO SWERVE AWAY FROM THE INSIDE OF THE CANNULA DEVICE. THIS EVENT OCCURRED ALTHOUGH THE SURGEON USED THE DEVICE ACCORDING TO THE SURGICAL TECHNIQUE. IT WAS REPORTED THAT THE BROKEN PART/FRAGMENT WAS REMOVED, AND NOTHING WAS LEFT IN THE BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310306 ↗
• MalfunctionJan 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE SURGEON USED THE CLEARCANNULA-THREADED 7.0MMX75MM 5PK-ST DEVICE AS USUAL. HOWEVER, THE DISK-SHAPED PLASTIC COMPONENT CAME OFF. IT WAS REPORTED THAT THE SURGEON, WHO HAS USED THIS DEVICE FOR MANY YEARS, NOTED THAT THEY HAD NEVER ENCOUNTERED SUCH DAMAGE BEFORE. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264273 ↗
• MalfunctionJan 8, 2025Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE CLEARCANNULA-THREADED 7.0MMX75MM 5PK -ST DEVICE HAD A LEAK IN THE SEALING HOLE OF THE THREADED CANNULA. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS FRACTURED BROKEN (2+ PIECES). IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103380 ↗
• MalfunctionMay 22, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARCR SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT WHEN THE SURGEON ATTEMPTED TO USE THE CLEAR CANNULA SYSTEM 7.0 X 75 MM ¿ THREADED DEVICE, THE INNER TUBE DID NOT GO IN SMOOTHLY AND GOT STUCK. THE SURGEON TRIED PULLING IT OUT AND REINSERTING IT SEVERAL TIMES; HOWEVER, IT DID NOT IMPROVE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369804 ↗
• MalfunctionDec 29, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE AFFILIATE IN RUSSIA THAT THE CLEAR CANNULA SYSTEM 7.0 X 75 MM ¿ THREADED DEVICE WAS NOT WAS NOT PACKED PROPERLY AS IT LET IN AIR; AND THEREFORE WAS NOT STERILE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075203 ↗
• MalfunctionFeb 2, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WAS A SMALL BLACK SPOT INSIDE THE PACKAGE OF THE CLEAR CANNULA-THREADED 7.0MMX75MM 5PK -ST DEVICE. THE PACKAGE WAS NOT OPENED AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13426443 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING A SHOULDER SCOPE PROCEDURE THE PURPLE TROCAR ON THE CUSTOMER'S 7.0 X 75MM FULLY THREADED CANNULA WHEN PULLING OUT FELL ON THE FLOOR AND BROKE. THE SALES REPRESENTATIVE STATED THAT THE DEVICE BROKE OFF BETWEEN THE HANDLE AND STEAM ONTO THE FLOOR. THE SALES REPRESENTATIVE CONFIRMED THAT THE DEVICE DID NOT BREAK IN THE PATIENT. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902837 ↗
• InjuryDec 5, 2017Break; Break

  THE SALES REP REPORTED VIA PHONE THAT AT THE END OF A SHOULDER ARTHROSCOPY THE SURGEON NOTICED THAT THERE WAS A CLEAR PLASTIC PIECE IN THE PATIENTS JOINT SPACE. THE SURGEON LOOKED AT THE 7.0X75MM FULLY THREADED CANNULA THAT WAS USED IN THE CASE AND NOTICED TAHT IT WAS DAMAGED. THE SURGEON WENT BACK INTO THE PATIENT AND USED A SHAVER TO REMOVE THE PLASTIC PIECE. THE SURGEON WAS CONFIDENT THAT HE HAD REMOVED THE PIECE BUT THE FIRST ASSIST STATED THAT THE PIECE WAS STILL IN THE PATIENT. THE SURGEON FELT CONFIDENT IT WAS REMOVED AND CLOSE THE PATIENT UP WITHOUT ANY ISSUES. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7084294 ↗