NA 214627Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705004096), received between Aug 16, 2018 and Feb 28, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2024Degraded; Use of Device Problem; Device-Device Incompatibility; Degraded; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED BY AN AFFILIATE IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE ARTHRO SUTURE CUTTER SLIDING DEVICE WAS MISSING A SCREW. THE CLAMP WAS DISASSEMBLED AND WOULD NOT CUT. THERE WAS NO DISCOMFORT FROM THE SPECIALIST. THERE WAS NO DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER CUTTER. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18802323 ↗
• MalfunctionJan 22, 2024Use of Device Problem; Use of Device Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE BOTH THE ARTHRO SUTURE CUTTER SLIDING DEVICE AND CORDCUTTER DEVICE ARRIVED WITHOUT THE INTERNAL TUBE TO CUT. IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. 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 18554080 ↗
• MalfunctionDec 5, 2023Degraded; Use of Device Problem; Degraded; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE PERFORMED ON (B)(6) 2023 IT WAS OBSERVED THAT TWO ARTHRO SUTURE CUTTER SLIDING *EA DEVICES WERE MISSING A SCREW AND COULD NOT BE USED, AND IT WAS VERY HARD TO CUT WITH THE DEVICES. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THERE WAS A UNSPECIFIED SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18269770 ↗
• MalfunctionDec 5, 2023Degraded; Use of Device Problem; Degraded; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE PERFORMED ON (B)(6) 2023 IT WAS OBSERVED THAT TWO ARTHRO SUTURE CUTTER SLIDING *EA DEVICES WERE MISSING A SCREW AND COULD NOT BE USED, AND IT WAS VERY HARD TO CUT WITH THE DEVICES. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THERE WAS A UNSPECIFIED SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18269577 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT PRIOR TO AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE CUTTING PORTION OF A SLIDING SUTURE CUTTER DEVICE HAD BROKEN OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940037 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021 IT WAS OBSERVED THAT THE ARTHRO SUTURE CUTTER SLIDING DEVICE WAS BROKEN. 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 13483660 ↗
• MalfunctionMar 25, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE CUTTER DEVICE WAS TOO DULL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568457 ↗
• MalfunctionMar 23, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SUTURE CUTTER DEVICE WAS NOT SHARP ENOUGH THAT IT WAS FRAYING THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556101 ↗
• MalfunctionNov 10, 2020Component Missing; Component Missing

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THESE PIECES OF INSTRUMENTS ARRIVED DAMAGED. IN THE EXPRESSW SHEARS THE TIP HAS HIT MARKS AND IS TWISTED AND DOES NOT ALLOW THE PLATE TO PROPERLY ASSEMBLE AND DID NOT WORK PROPERLY, WHICH CAUSED THE PLATE TO REMAIN INSIDE THE PATIENT'S JOINT, FINALLY THE SPECIALIST MANAGED TO REMOVE IT. AND THE SUTURE CUTTER DOES NOT HAVE THE SCREW THAT HOLDS THE INTERNAL PART, FOR THIS REASON IT DOES NOT WORK AND COULD NOT BE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10819452 ↗
• MalfunctionJul 24, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REPRESENTATIVE VIA EMAIL THAT SOME OF THE DELIVERED ARTHRO SUTURE CUTTER SLIDING *EA INSTRUMENTS VERY DIFFICULT TO OPEN (EVEN IF THEY OPEN CORRECTLY THE LOCK SYSTEM INCLUDED IN THE INSTRUMENTS CONCERNED). THE SALES REPRESENTATIVE WAS NOT PRESENT WHEN THIS WAS DISCOVERED AND COULD NOT CONFIRM THE CONDITION OF THE INSTRUMENT. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE REPORTED THERE ARE STILL SOME TRAYS FOR THESE INSTRUMENTS TO BE DELIVERED SOME COMPONENTS ARE IN BACK ORDER. THE CUSTOMER CAN STILL NOT SEND THE INSTRUMENTS TO BE STERILISED AND THEY DON¿T WANT TO OPEN THE INSTRUMENTS RECEIVED BECAUSE THEY DON¿T WANT TO TAKE THE RISK TO DAMAGE IT WITHOUT TRAYS. IT WAS ALSO REPORTED THE HOSPITAL IS AN ESTABLISHMENT WHICH HAS OPENED RECENTLY NEW THEATRE BUT THEY STILL DON¿T OPERATE OR HAVE ANY ACTIVITIES ON THEATRE AS THEY NEED TO MAKE SURE TO FOLLOW ALL THE TRAININGS REQUIRED AND PROVIDED BY THE MEDICAL INDUSTRIES TO BE QUALIFIED TO USE EQUIPMENT AND MATERIAL. AN ESTABLISHMENT WHICH HAS OPENED RECENTLY NEW THEATRE BUT THEY STILL DON¿T OPERATE OR HAVE ANY ACTIVITIES ON THEATRE AS THEY NEED TO MAKE SURE TO FOLLOW ALL THE TRAININGS REQUIRED AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323276 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN UNITED KINGDOM THAT DURING SHOULDER STABILIZATION PROCEDURE, IT WAS OBSERVED THATTHE ARTHRO SUTURE CUTTER SLIDING KIT WAS BLUNT. ACCORDING TO THE REPORT, THE DEVICE WAS NOT USED PREVIOUSLY AND WAS ON ITS FIRST USE. THERE WAS A DELAY IN THE SURGICAL PROCEDURE OF 45 MINUTES TO AN HOUR WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WAS A ANOTHER ARTHROSCOPIC SCISSOR FROM COMPETITOR 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: Not Applicable

  MAUDE report 9129019 ↗
• MalfunctionAug 16, 2018Break; Break

  THE SALES REP REPORTED HIS SUTURE CUTTER'S BROKE WHILE USING THEM IN A DEMO. HE STATED THE DEVICE WAS NOT USED IN A PROCEDURE AND WHEN HE WENT TO CUT THE SUTURES, A PIECE INSIDE THE DEVICE CAME OUT AND THE WHOLE DISTAL END OF THE DEVICE FELL APART. HE STATED THE DEVICE HAD SEEN HEAVY USE AND WAS VISIBLY WORN. THERE WERE NO PATIENT CONSEQUENCES AND THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788902 ↗