NA 214615Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886705003983), received between May 9, 2018 and Feb 4, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Deformation

  INITIALLY IT WAS REPORTED BY SALES REP VIA PHONE THAT THE ARTHRO KNOT MANIP FULL *EA HAD AN UNSPECIFIED MALFUNCTION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS CUTTING SUTURE WHEN TYING KNOTS. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256785 ↗
• MalfunctionJan 15, 2026Material Deformation

  IT WAS REPORTED THAT THE RING OF THE ARTHRO KNOT MANIP FULL DEVICE HAS BECOME SHARP AND CUTTING SUTURE WHILE TIGHTENING KNOTS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085242 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ARTHRO KNOT MANIP FULL *EA KNOT REMOVER CUT TWO SUTURES WHEN LOWERING THE FIRST KNOT, WHICH CAUSE A LOT OF DISCOMFORT TO THE SURGEON. IT WAS FURTHER OBSERVED THAT THE CORDCUTTER *EA DEVICE WAS VERY HARD AND DID NOT ALLOW TO CUT THE SUTURES WELL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR 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 20212770 ↗
• MalfunctionFeb 28, 2024Break; Mechanical Problem; Material Deformation; Break; Mechanical Problem; Material Deformation

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE ARTHRO KNOT MANIP FULL WHEN THE SUTURE IS TIGHTENED WITH THE LOW KNOTS THIS BEGINS TO WEAKEN AND FRAYED THE SUTURE UNTIL IT CUTS IT COMPLETELY, IN THE UPPER PART YOU FEEL A SLIGHT EDGE LOW KNOTS CUTS THE SUTURE, IF THERE WAS DISCOMFORT OF THE SPECIALIST, DID NOT DELAY THE SURGERY, IT WAS SUCCESSFULLY ACHIEVED, ANOTHER REPORT LOW KNOTS SUTURE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797041 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN FRANCE THAT A KNOT PUSHES FROM A ARTHRO KNOT MANIP FULL *EA CUFF BOX THAT BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672439 ↗
• MalfunctionApr 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE KNOT MANIPULATOR FULL LOOP DEVICE WAS DAMAGING THE SUPERSUTURES AT THE TIME OF LOWERING THE KNOT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH 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 16743430 ↗
• MalfunctionMar 23, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE KNOT MANIPULATOR FULL LOOP DEVICE WAS BENT. 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 16600867 ↗
• MalfunctionDec 29, 2022Crack; Crack

  IT WAS REPORTED BY SALES REP THAT DURING AN ARTHROSCOPIC LABRAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE KNOT MANIPULATOR FULL LOOP DEVICE TORE THROUGH TWO STITCHES. ACCORDING TO THE REPORT, THE TEAM HAD TO DRILL TWO ADDITIONAL ANCHORS INTO THE PATIENT DUE TO THE ISSUES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 15 MINUTE 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 16073032 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE RIP ON THE TIP OF THE KNOT MANIPULATOR FULL LOOP DEVICE BROKE WHILE THE SURGEON WAS PERFORMING TO TIE THE KNOT. 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 15301216 ↗
• MalfunctionMar 17, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER IN AUSTRALIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE ARTHRO KNOT MANIP FULL DEVICE WAS BENT. 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 13792334 ↗
• MalfunctionJan 20, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022, THE ARTHRO KNOT MANIP FULL IS FRAYING THE SUTURE. ANOTHER DEVICE 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 13307071 ↗
• MalfunctionJan 20, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022, THE ARTHRO KNOT MANIP FULL IS FRAYING THE SUTURE. ANOTHER DEVICE 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 13306989 ↗
• MalfunctionJan 20, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022, THE ARTHRO KNOT MANIP FULL IS FRAYING THE SUTURE. ANOTHER DEVICE 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 13306932 ↗
• MalfunctionDec 8, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON 11/30/2021, IT WAS OBSERVED THAT THE ARTHRO KNOT MANIP FULL DEVICE BROKE THE SUTURE AFTER THE KNOT WAS ALREADY TIGHTENED. 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 12964152 ↗
• MalfunctionDec 12, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER SCOPE PROCEDURE ON AN UNKNOWN DATE THE SHAFT ON THE CUSTOMER'S KNOT MANIPULATOR FULL LOOP IS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION OR A LOT NUMBER FOR THE DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460828 ↗
• MalfunctionNov 20, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING A SHOULDER ARTHROSCOPY THE ARTHRO KNOT MANIP FULL *EA WAS FOUND TO BE BROKEN, BEFORE SURGEON HAD TO USE IT. THERE WAS NO SIGN OF THE BROKEN TIP IN THE TRAY. PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9348484 ↗
• MalfunctionJan 16, 2019Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, THE SCRUB TECH DROPPED HIS KNOT MANIPULATOR FULL LOOP ON THE OPERATING ROOM FLOOR AND THE BLACK LOOP BROKE OFF. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER BUT REPORTED THAT THE DEVICE WAS UNDER A YEAR OLD. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8252135 ↗
• MalfunctionJan 10, 2019Break; Break

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER, IT WAS OBSERVED THAT THE CUSTOMER'S HEALIX AWL BROKE MID-SHAFT WHEN PREPPING THE BONE TUNNEL WHILE IN USE WITH TWO KNOT MANIPULATORS FULL LOOP DEVICES THAT WERE CUTTING SUTURE. THE SALES REP CONFIRMED THAT NOTHING BROKE OR FELL INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICES WITH NO PATIENT CONSEQUENCES. THERE WAS A NINE MINUTE DELAY REPORTED TO COMPLETE THE PROCEDURE. THE SALES REP REPORTED THAT THE CUSTOMER DID USE FIBERWIRE. THE SALES REP COULD NOT PROVIDE THE LOT NUMBERS FOR THE DEVICES BUT REPORTED THAT THEY WERE ALL OVER FOUR YEARS OLD AND HAD BEEN HEAVILY USED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237521 ↗
• MalfunctionJan 10, 2019Break; Break

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER, IT WAS OBSERVED THAT THE CUSTOMER'S HEALIX AWL BROKE MID-SHAFT WHEN PREPPING THE BONE TUNNEL WHILE IN USE WITH TWO KNOT MANIPULATORS FULL LOOP DEVICES THAT WERE CUTTING SUTURE. THE SALES REP CONFIRMED THAT NOTHING BROKE OR FELL INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICES WITH NO PATIENT CONSEQUENCES. THERE WAS A NINE MINUTE DELAY REPORTED TO COMPLETE THE PROCEDURE. THE SALES REP REPORTED THAT THE CUSTOMER DID USE FIBERWIRE. THE SALES REP COULD NOT PROVIDE THE LOT NUMBERS FOR THE DEVICES BUT REPORTED THAT THEY WERE ALL OVER FOUR YEARS OLD AND HAD BEEN HEAVILY USED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237490 ↗
• MalfunctionOct 25, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A RIGHT ARTHROSCOPIC POSTERIOR LABRAL REPAIR, WHEN THE SURGEON WAS USING KNOT PUSHER HE NOTED THE SUTURE BROKE PREMATURELY AND STATED THAT THERE WAS A SMALL CUT IN THE TIP OF THE KNOT PUSHER, CAUSING THE SUTURE TO BREAK. SURGEON WAS ABLE TO SALVAGE SUTURE AND RE-TIE. IT WAS REPORTED THAT FOR THE REMAINDER OF THE CASE, THE SURGEON USED AN ALTERNATIVE KNOT PUSHER 210835 WITHOUT INCIDENT. IT WAS REPORTED THAT THERE WAS FIVE MINUTE DELAY TO PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S STATUS POST-SURGERY WAS STABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8004242 ↗
• MalfunctionOct 10, 2018Break; Break

  ADDITIONAL EVENT INFORMATION RECEIVED ON 10/23/2018. ENGINEERS ASSESSMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951144 ↗
• MalfunctionAug 17, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF PROCEDURE THEIR KNOT MANIPULATOR WAS DROPPED ON THE FLOOR AND THE TIP OF THE DEVICE BROKE. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS APPROXIMATELY A YEAR OLD. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794772 ↗
• MalfunctionAug 16, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR, THE SCRUB TECH DROPPED HIS KNOT MANIPULATOR FULL LOOP AND BROKE THE DEVICE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER BUT REPORTED THAT THE DEVICE WAS LESS THAN 1 YEARS OLD. THE CUSTOMER DISCARDED THE DEVICE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7791844 ↗
• MalfunctionAug 16, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, THE SCRUB TECH DROPPED HIS KNOT MANIPULATOR FULL LOOP AND BROKE THE DEVICE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER BUT REPORTED THAT THE DEVICE WAS LESS THAN 6 MONTHS OLD. THE CUSTOMER DISCARDED THE DEVICE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7791828 ↗
• MalfunctionAug 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE THEIR KNOT MANIPULATOR WAS DROPPED ON THE FLOOR AND BROKE. THE SALES REP WAS UNSURE WHERE ON THE DEVICE DID IT BREAK. HE STATED THAT THE DEVICE WAS PUT IN THE SHARP BIN BEFORE HE COULD LOOK AT THE DEVICE. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS A NEWER DEVICE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7775537 ↗