ARC C08-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20653405001635), received between Aug 16, 2018 and Aug 30, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2021Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, C08-65, WAS BEING USED ON 8JUL21 DURING A ROTATOR CUFF REPAIR PROCEDURE AND THE ¿SURGEON WAS INSERTING CANNULA INTO SHOULDER AND 1 CANNULA PARTIAL DISTAL FLANGE SNAPPED OFF. OPENED SECOND CANNULA AND WHOLE DISTAL TIP AND FLANGE BROKE OFF. ALL PART OF CANNULA REMOVED SAFELY FROM PATIENT.¿ THERE WAS A TWO MINUTE DELAY AND THE PROCEDURE WAS COMPLETED WITH AN ARTHREX PASSPORT CANNULA. THE ARTHREX PASSPORT CANNULA WILL BE LISTED AS A CONCOMITANT DEVICE. THERE WAS NO PATIENT INJURY OR IMPACT TO THE 75 YEAR OLD, MALE PATIENT WEIGHING 98KG AND NO FURTHER INTERVENTION REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385541 ↗
• MalfunctionSep 10, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT C08-65 DEVICE WAS BEING USED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2019. IT WAS REPORTED THAT "ARC BROKE AT THE NECK POINT WHILE INSERTING." THE PICTURES THAT WERE SENT SHOW THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE EVENT CAUSED A 20-MINUTE DELAY; HOWEVER, THERE WAS NO REPORT OF USER OR PATIENT INJURY AND NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8983706 ↗
• MalfunctionApr 11, 2019Material Fragmentation; Material Fragmentation

  ON BEHALF OF THE CUSTOMER, THE DISTRIBUTOR REPORTED AN ISSUE WITH AN ADJUSTABLE RETRACTOR CANNULA, CATALOG # C08-65, LOT: 201712261 THAT OCCURRED (B)(6) 2019 DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR. IT WAS REPORTED THAT "DURING THE SURGERY, THE PART OF TIP OF THIS PRODUCT WAS SHAVED OFF. FORTUNATELY, THE SHAVED PIECE WAS FOUND AND REMOVED FROM THE PATIENT'S BODY." IT IS INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAY. ADDITIONAL INFORMATION OBTAINED INDICATES THAT THERE WAS NO PROBLEM WITH INSERTION OF THE CANNULA. THE ONLY AVAILABLE INFORMATION ABOUT WHAT DEVICE(S) WERE USED WITH THE CANNULA WAS THAT A SHAVER WAS USED. IT IS INDICATED THAT THE SHAVED PIECE THAT FELL OFF OF THE CANNULA WAS RETRIEVED FROM THE PATIENT WITH THE VACUUMING OF WASTE LIQUID. ALTHOUGH ASKED, NO OTHER INFORMATION WAS MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE (FRAGMENTATION FALLING IN THE PATIENT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506454 ↗
• MalfunctionMar 13, 2019Break; Break

  ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED AN ISSUE WITH THE ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM, ITEM C08-65, LOT # 201809171. IT WAS REPORTED THAT THE DEVICE "DOESN'T WORK PROPERLY" - THE OUTER WINGS OF THE CANNULA BECAME TORN IN THE MIDDLE OF REMOVING THE FORCEPS. ADDITIONAL CLARIFICATION AND INFORMATION RECEIVED INDICATES THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2019 THE SURGEON MADE A SMALL INCISION WITH A SCALPEL AND INSERTED THE C08-65 WITH ARC-1000 FORCEPS. THE OUTER WINGS OF THE CANNULA WERE TORN WHEN REMOVING THE FORCEPS FROM INCISION SITE. THE WING OF THE CANNULA DID TEAR AND DETACH (RIP-OFF) WHILE STILL INSIDE THE PATIENT AND WAS REMOVED IMMEDIATELY BY HAND BY THE SURGEON. THERE WERE NO FRAGMENTS OR PIECES LEFT FREE-FLOATING IN THE PATIENT. THERE WAS NO REPORTED IMPACT OR INJURY TO THE PATIENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE WITH A 10-MINUTE REPORTED DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418200 ↗
• MalfunctionAug 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE C08-65, ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM, DEVICE HAD A WHITE WASHER/SEAL COME OUT OF THE DEVICE AND FALL INTO THE PATIENT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2018. THE WASHER WAS REMOVED FROM THE PATIENT CAUSING A 10-MINUTE DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF HARM TO THE PATIENT OR THE USER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. REQUEST FOR FURTHER INFORMATION HAVE BEEN SENT; HOWEVER, NO OTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790615 ↗