NA 214118Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705003594), received between Apr 9, 2019 and Sep 5, 2025 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE CLEARCANNULA-THREADED 8.5MMX55MM DEVICE WAS INSERTED THROUGH THE ANTEROLATERAL PORTAL TO PASS THE HEALIX TAPE ACROSS THE ROTATOR CUFF. THE TAPE WAS RETRIEVED USING A RETRIEVER, APPLIED TO THE AUTO-CAPTURE, AND INSERTED INTO THE CANNULA. AT THAT MOMENT, A SILICONE-LIKE SUBSTANCE APPEARED TO COME OUT FROM THE TIP OF THE CANNULA, LIKELY FROM INSIDE THE SEAL. THE SILICONE WAS REMOVED FROM THE ANTERIOR PORTAL. ITS SHAPE WAS EXAMINED, AND IT WAS CONFIRMED THAT NO REMNANTS REMAINED IN THE PATIENT'S BODY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. 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 22983556 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT DURING PRE-SURGERY FOR AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE CLEARCANNULA-THREADED 8.5MMX55MM DEVICE TIP WAS BROKEN. THERE WAS NO 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 21343124 ↗
• MalfunctionMay 9, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE PACKING BROKE ON THE CLEARCANNULA-THREADED 8.5MMX55MM 5PK -ST DEVICE WHEN IT WAS UNSEALED AND TRIED TO PLACE THE INNER COMPONENT. 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 14337230 ↗
• MalfunctionApr 9, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A SHOULDER ARTHROSCOPY THE IMPLANTED TROCAR DIDN'T RESIST DURING THE PASSAGE OF THE CLAMP. THE CAOUTCHOUC WHICH IS USED AS A VALVE DETACHED FROM THE DEVICE AND THE CAOUTCHOUC WAS LOCATED IN THE JOINT. THE SURGEON IMMEDIATELY REMOVED THE CAOUTCHOUC FROM THE JOINT. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTING A 15 MINUTE DELAY. THE AFFILIATE ALSO REPORTED THAT THE SURGEON WAS ABLE TO REMOVE ALL BROKEN PIECES FROM THE PATIENT JOINT.

  Patient problems: Not Applicable

  MAUDE report 8498090 ↗