NA 214120Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886705003617), received between Oct 4, 2018 and Sep 15, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that during an unspecified surgery, the internal sealing component of the THREADED CLEAR CANNULA was detached. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769536 ↗
• MalfunctionAug 26, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460756 ↗
• MalfunctionAug 26, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460754 ↗
• MalfunctionAug 26, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460750 ↗
• MalfunctionJan 15, 2026Leak/Splash; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. IT WAS INITIALLY REPORTED THAT THE DEVICE THE VALVE LOCATED AT THE DEVICE'S INLET REMAINED OPEN, CAUSING EXCESSIVE LEAKAGE OF SALINE SOLUTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 24082383 ↗
• MalfunctionAug 21, 2025Leak/Splash; Increase in Pressure; Detachment of Device or Device Component; Leak/Splash; Increase in Pressure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CLEARCANNULA-THREADED DEVICE WAS INTRUDED THROUGH THE PORT THE CLAMPS WERE INTRODUCED TO RECOVER THE SUTURES AND THIS PRESENTED WATER LEAKAGE THROUGH THE INLET OF THE PUNCH WHICH CAUSES THE PRESSURE IN THE JOINT TO BE LOST, DURING CX A RUBBER PART OF THE CANULA WAS OBSERVED INSIDE THE SHOULDER. THERE WERE NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22865525 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE CLEARCANNULA-THREADED 8.5MMX75MM 5PK DEVICE FLANGE IN THE CANNULA RIPPED OFF INSIDE OF THE CANNULA. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796769 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART REPAIR (ABR) SURGICAL PROCEDURE AND ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, WHEN THE SURGEON PERFORMED A BRIDGING PROCEDURE WITH A COMPETITOR¿S LATERAL 5.5 EXTERNAL ANCHOR, THE DEVICE BECAME STUCK INSIDE THE CLEARCANNULA-THREADED 8.5MMX75MM CANNULA DEVICE. THE SURGEON INSERTED A SWITCHING ROD INTO THE 8.5 CANNULA AND CHECKED THE CONDITION. IT WAS REPORTED THAT THE SWITCHING ROD HAD DIFFICULTY IN PASSING THROUGH THE CANNULA. IT WAS REPORTED THAT THE SURGEON OPENED A NEW CLEARCANNULA-THREADED 8.5MMX75MM CANNULA DEVICE. OUTSIDE THE BODY, AN ANCHOR PASSED THROUGH THE NEW 8.5 CANNULA, BUT INSIDE THE BODY, COMPETITOR¿S LATERAL 5.5 ANCHOR STILL HAD A RESISTANCE IN PASSING THROUGH THE NEW 8.5 CANNULA AND BECAME STUCK. THE SURGEON STOPPED USING THE CLEARCANNULA-THREADED 8.5MMX75MM CANNULA DEVICES AND COMPLETED THE SURGERY SUCCESSFULLY WITH A COMPETITOR¿S CANNULA. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727238 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART REPAIR (ABR) SURGICAL PROCEDURE AND ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, WHEN THE SURGEON PERFORMED A BRIDGING PROCEDURE WITH A COMPETITOR¿S LATERAL 5.5 EXTERNAL ANCHOR, THE DEVICE BECAME STUCK INSIDE THE CLEARCANNULA-THREADED 8.5MMX75MM CANNULA DEVICE. THE SURGEON INSERTED A SWITCHING ROD INTO THE 8.5 CANNULA AND CHECKED THE CONDITION. IT WAS REPORTED THAT THE SWITCHING ROD HAD DIFFICULTY IN PASSING THROUGH THE CANNULA. IT WAS REPORTED THAT THE SURGEON OPENED A NEW CLEARCANNULA-THREADED 8.5MMX75MM CANNULA DEVICE. OUTSIDE THE BODY, AN ANCHOR PASSED THROUGH THE NEW 8.5 CANNULA, BUT INSIDE THE BODY, COMPETITOR¿S LATERAL 5.5 ANCHOR STILL HAD A RESISTANCE IN PASSING THROUGH THE NEW 8.5 CANNULA AND BECAME STUCK. THE SURGEON STOPPED USING THE CLEARCANNULA-THREADED 8.5MMX75MM CANNULA DEVICES AND COMPLETED THE SURGERY SUCCESSFULLY WITH A COMPETITOR¿S CANNULA. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727234 ↗
• MalfunctionJul 31, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE CLEARCANNULA-THREADED 8.5MMX75MM DEVICE LOOSENED THE ENTIRE RUBBER. IT WAS NOT REPORTED WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674044 ↗
• MalfunctionFeb 10, 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 PLASTIC CAP ON THE CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST DEVICE, WHICH SEALS THE CANNULA, FELL INTO THE PATIENT¿S SHOULDER. THE PLASTIC CAP WAS REMOVED FROM THE PATIENT. 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JANUARY 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21347071 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO A ROTATOR CUFF REPAIR PROCEDURE IT WAS OBSERVED THAT THE THREAD OF THE CLEAR CANNULA SYSTEM 8.5 X 75 MM WAS RIPPED OUT. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273493 ↗
• MalfunctionApr 24, 2024Break; Break

  IT WAS REPORTED FROM AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE YELLOW CLEARCANNULA-THREADED 8.5MMX75MM DEVICE HAD THE CLEAR INSERTER SNAP OFF. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173263 ↗
• MalfunctionSep 6, 2022Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A JOINT LIP ARTHROPLASTY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TRANSPARENT CYLINDRICAL COMPONENT (WHERE A PLASTIC-LIKE RING WAS ATTACHED TO) HAD ALREADY CRACKED AND COME OFF THE UNIT WHEN THE CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED DEVICE WAS UNSEALED. 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 15364707 ↗
• MalfunctionAug 25, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN BRAZIL THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED DEVICE WAS LEAKING AND BROKEN. 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 15294117 ↗
• MalfunctionFeb 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE PLASTIC VALVE CAME OFF OF THE CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST DEVICE. THERE WAS AN UNSPECIFIED DELAY. 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 13501026 ↗
• MalfunctionFeb 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE RUBBER SEAL WAS DEFECTIVE ON THE CLEAR CANNULA-THREADED 8.5MMX75MM DEVICE THAT IT CAME LOOSE AND FLOATED AROUND IN THE SITUS. IT WAS REPORTED THAT THROUGH EXTENSIVE SEARCHING IT WAS RECOVERED. 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 13417753 ↗
• MalfunctionSep 14, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RUBBER BUNG ON THE CLEARCANNULA-THREADED 8.5MMX75MM DEVICE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467337 ↗
• MalfunctionMar 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RUBBER GASKET ON THE CANNULA DEVICE CAME OFF AND WENT THROUGH THE SHOULDER JOINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556048 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RUBBER BUNG INSIDE A CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED DEVICE BROKE. THE BROKEN PIECE COULD BE SEEN ARTHROSCOPICALLY ON CAMERA AND WAS REMOVED. THERE WERE NO REMAINS OF THE BROKEN PART SEEN AFTER REMOVAL. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. AN ARTHROSCOPIC GRASPER DEVICE WAS USED TO REMOVE THE BROKEN PARTS TO COMPLETE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439005 ↗
• MalfunctionSep 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL, THE CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST. DURING A SHOULDER OPERATION, THE SEALING RING CAME LOOSE FROM THE THREADED CLEAR CANNULA WITH OBTURATOR 8,5 MM X 75 MM. SEALING RING WAS THUS FREE IN THE PATIENT'S SHOULDER JOINT. FORTUNATELY, WE WERE ABLE TO REMOVE THE EXPOSED SEALING RING. THERE WAS A SURGICAL DELAY OF 5 MINUTES. NO PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10525410 ↗
• MalfunctionDec 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER ARTHROSCOPIC SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CLEAR WASHER ON THE CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST DEVICE CAME APART FROM THE CANNULA AND ENDED UP IN PATIENT'S SHOULDER. ACCORDING TO THE REPORT, THE DEVICE WAS BEING USED AS A PORTAL INTO THE SHOULDER TO BE ABLE TO USE THE ARTHROSCOPIC INSTRUMENTS TO BE INSERTED. THIS WAS NOTED BY THE SCRUB TEAM AND THE WASHER WAS ABLE TO BE REMOVED WITH NO CONSEQUENCES. THIS WAS COMPLETED AS A "NEAR MISS". THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9497638 ↗
• MalfunctionDec 12, 2019Disconnection; Disconnection

  IT WAS REPORTED BY THE AFFILIATE, VIA COMPLAINT SUBMISSION TOOL, DURING A SHOULDER BANKHARDT LABRUM REPAIR, THE SURGEON INSERTED ONE 8.5X75 YELLOW CANNULA 214120 INTO THE SHOULDER AND ONE OF THE RUBBER DAMS COLLAPSED INTO THE CANNULA BODY. IT WAS REPORTED THE SURGEON REMOVED THE CANNULA AND INSERTED ANOTHER ONE. THE SURGEON REPORTEDLY REMOVED ALL FRAGMENTS WITH EASE AND DID NOT REQUIRE ADDITIONAL SURGICAL INTERVENTION. NO PATIENT HARM, CONSEQUENCES, OR SURGICAL DELAY WERE REPORTED. THE SURGEON COMMENTED TO THE AFFILIATE THAT THIS WAS THE SECOND OR THIRD 8.5X75 YELLOW CANNULA TO DO THIS WITHIN A COUPLE WEEKS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9459298 ↗
• MalfunctionNov 26, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE PLASTIC OF THIS CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 10 MINUTES DELAY. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Not Applicable

  MAUDE report 9376715 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR, THE CLEAR OUTLET PORT ON THE SIDE OF HER CLEAR THREADED CANNULA BROKE RIGHT OFF OF THE CANNULA. THE SURGEON TRIED A SECOND ONE FROM THE SAME LOT NUMBER, AND IT ALSO BROKE. HE THEN TRIED A THIRD FROM THE SAME LOT NUMBER, BUT WAS CAREFUL NOT TO PUT ANY PRESSURE ON IT, AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. BOTH DEVICES WERE DISCARDED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9071476 ↗