FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® Sutu AR-4570Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10818674021798), received between Dec 26, 2019 and Jul 9, 2024 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A MENISCUS RE-FIX SURGERY THE SECOND IMPLANT OF FOUR FIBERSTITCH COULD NOT BE IMPLANTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702617 ↗
• MalfunctionJul 9, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A MENISCUS RE-FIX SURGERY THE SECOND IMPLANT OF FOUR FIBERSTITCH COULD NOT BE IMPLANTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702566 ↗
• MalfunctionNov 21, 2023

  DURING THE SURGICAL PROCEDURE, THERE WAS 1 AREA IN THE POSTERIOR ASPECT WHERE THIS ANCHOR FAILED AND PER THE SURGICAL REPORT, "LED TO SOME ADDITIONAL MENISCUS TEARING IN THIS REGION." THE METAL TIP OF THIS ANTHREX FIBERSTITCH DEVICE BROKE COMPLETELY AND HAD TO BE RETRIEVED FROM INSIDE THE PATIENT'S KNEE. THE NEEDLE TIP WAS EASILY VISUALIZED AND REMOVED WITHOUT INCIDENT. THE REPORT STATES, "OUT OF AN ABUNDANCE OF CAUTION AT THE END OF THE CASE X-RAYS WERE PERFORMED. NO METALLIC FOREIGN BODY WAS IDENTIFIED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181475 ↗
• InjuryJan 27, 2020Malposition of Device

  IT WAS REPORTED THAT A CURVED FIBERSTITCH IMPLANT, AR-4570, WAS BEING USED DURING A KNEE ARTHROSCOPY PROCEDURE. WHEN THE SECOND IMPLANT WAS DEPLOYED BEHIND THE CAPSULE, THE IMPLANT STAYED ON THE NEEDLE AND THE NEEDLE CAME OUT OF THE FIBERSTITCH HANDLE. THE FIBERSTITCH HANDLE WAS REMOVED PER TECHNIQUE. THE PATIENT WASN'T HARMED AND THE NEEDLE WAS REMOVED FROM THE PATIENT WITHOUT CAUSING ANY DAMAGE. ADDITIONAL INFORMATION PROVIDED 01/07/2020: THE FIRST IMPLANT WAS NOT REMOVED AND REMAINED IN THE CAPSULE. THE CASE WAS COMPLETED WITH A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: No Information

  MAUDE report 9631367 ↗
• InjuryJan 20, 2020Break; Entrapment of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON WAS UTILIZING A FIBERSTITCH IMPLANT, AR-4570, LOT: 19K24. THE SURGEON WAS ATTEMPTING TO REPAIR THE MEDIAL MENISCUS ON A PATIENTS LEFT KNEE. UPON INSERTING THE AR-4570 DEVICE UTILIZING THE AR-4505 PORTAL SKID INTO THE MEDIAL PORTAL, SELECTING THE IMPLANT LOCATION AND BEGINNING THE PROCESS OF REPAIRING THE MENISCUS THE FOLLOWING TOOK PLACE: THE MENISCUS WAS PENETRATED WITH THE DEVICE, AND THE DEPTH STOP SET TO 18MM. THE DEVICE WAS INSERTED SO THAT THE DEPTH STOP MADE CONTACT WITH THE MENISCUS AND THEN THE TOGGLE WAS ROLLED TOWARD THE SURGEON UNTIL AN AUDIBLE CLICK WAS HEARD AND THE FIRST IMPLANT WAS DEPLOYED. THE TOGGLE WAS THEN ROLLED ALL THE WAY FORWARD AND THE DEVICE WAS REMOVED FROM THE MENISCUS. AFTER SELECTING A SECOND LOCATION AND PENETRATING THE MENISCUS, THE TOGGLE SWITCH WAS ROLLED TOWARD THE SURGEON FOR A SECOND TIME, HOWEVER THE DEVICE TOGGLE SWITCH WOULD NOT ROLL EASILY. THE SURGEON WAS ABLE TO FORCE THE TOGGLE SWITCH, WITH SOME DIFFICULTY, TO BE ROLLED COMPLETELY TOWARD HIM, IN THE EXACT SAME MANNER AS THE FIRST IMPLANT. THE DEVICE DID NOT GIVE AN AUDIBLE CLICK. THE SURGEON ROLLED THE TOGGLE COMPLETELY

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 9607437 ↗
• MalfunctionJan 20, 2020Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT A CURVED FIBER STITCH IMPLANT, AR-4570, WAS BEING USED IN A MENISCUS REPAIR PROCEDURE. WHEN ATTEMPTING THE FIRST PLUNGE, THE NEEDLE BENT, THEN APPEARED TO SHEAR OFF. IT STAYED IN THE PLASTIC DEPTH STOP, AND SO DID NOT COME LOOSE AS A SEPARATE PIECE FROM THE DEVICE. THE SURGEON REMOVED THE DEVICE IN ONE PIECE. HE WAS ABLE TO COMPLETE THE MENISCAL REPAIR WITH ANOTHER ALL-INSIDE DEVICE WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9607432 ↗
• InjuryJan 20, 2020Break

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A LATERAL MENISCUS REPAIR WITH THE FIBER STITCH IMPLANT, AR-4570, APPROACHING THE MENISCUS FROM THE LATERAL PORTAL. FOR BOTH DEVICES, WHEN HE WAS REPAIRING THE POSTERIOR MENISCUS NEAR THE HORN, HE HAD LOTS OF TORQUE ON THE HANDLE AND WHEN HE TRIED TO IMPLANT THE SECOND ANCHOR, THE TIP BROKE OFF. HE RETRIEVED BOTH TIPS AND NOTHING WAS LEFT IN THE PATIENT. ALTHOUGH THE USER PUT TORQUE ON THE DEVICE, IT WAS INTERESTING TO NOTE THAT THE DEVICE BROKE IN THE SAME SPOT ON BOTH TIPS. ADDITIONAL INFORMATION PROVIDED 1/3/2019: THE FIRST IMPLANTS FROM BOTH DEVICES REMAINED BEHIND THE CAPSULE WITH THE SUTURE CUT-OFF FROM THE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9607430 ↗
• InjuryJan 20, 2020Output Problem

  IT WAS REPORTED THAT TWO CURVED FIBERSTITCH IMPLANTS, AR-4570, WERE BEING USED IN A PROCEDURE. FIRST DEVICE, WAS UTILIZED EXACTLY LIKE THE TECHNIQUE REQUIRES; HOWEVER, THE SECOND IMPLANT WOULD NOT KICK OUT OF THE TROCAR. THE SURGEON RE-INSERTED AND IT STILL WOULD NOT KICK OUT OF THE SHEATH. THE SUTURE WAS CUT AND THE DEBRIS REMOVED. THE SECOND DEVICE, WAS DEPLOYED JUST AS THE FIRST. NO FAULT, NO ISSUE. OPERATION WAS SMOOTH. THE FIRST LOOP WAS REDUCED, BUT UPON REDUCING THE SECOND LOOP, THE DEVICE LOCKED AND WOULD NOT TIGHTEN DOWN TO THE MENISCUS. THE SUTURES WERE CUT, EXCESS WAS CLEANED UP AND NO HARM WAS DONE TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED: 01/03/2020: THE IMPLANTS FROM BOTH DEVICES WERE LEFT BEHIND IN THE PATIENT (4 TOTAL), BUT THE SUTURE BETWEEN BOTH IMPLANTS WAS CUT OUT. A LEFT NOTCH SHOULDER CUTTER WAS USED AND A SHAVER TO REMOVED ALL DEBRIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9607421 ↗
• InjuryDec 26, 2019Break; Device Slipped

  IT WAS REPORTED DURING AN ACL RECONSTRUCTION WITH MENISCAL REPAIR PROCEDURE, A QUANTITY TWO AR-4570 FIBERSTITCH IMPLANTS FROM LOT: 19K24 WERE IMPLANTED SUCCESSFULLY. UPON TRYING TO INSERT THE THIRD AR-4570 (LOT: 19K24), THE TIP OF THE DEVICE BROKE. THE BROKEN TIP WAS FULLY RETRIEVED AND REMOVED FROM THE PATIENT BY USING A GRASPER. A FOURTH AR-4570 FROM THE SAME LOT WAS THEN BROUGHT IN. THE FIRST IMPLANT DEPLOYED AND IMPLANTED FINE. THE SURGEON THEN ATTEMPTED TO IMPLANT THE SECOND IMPLANT, BUT UPON REMOVING THE DEVICE FROM THE JOINT THE SECOND IMPLANT CAME OUT WITH THE DEVICE. THE SURGEON CUT THE SUTURE OF THE FIRST IMPLANT THAT WAS IN THE PATIENT, AND ALL PORTIONS OF THE FIRST IMPLANT WAS REMOVED FROM THE JOINT. THE REP STATED THE KNEE WAS VERY TIGHT, AND IT WAS VERY DIFFICULT FOR THE SURGEON TO MOVE AROUND WITHIN THE JOINT. THE SURGEON SWITCHED TO ANOTHER MANUFACTURERS DEVICE TO CONTINUE THE PROCEDURE. HOWEVER, THE SURGEON WAS STILL HAVING ISSUES WITH REPAIRING THE MENISCUS. THE SURGEON SWITCHED TO MENISCECTOMY, AND REMOVED A PORTION OF THE MENISCUS TO COMPLETE THE CASE. THE FIRST BROKEN AR-4570 AND RETRIEVED TIP WILL BE RETURNING FOR EVALUATION. THE SALES REP REPORTED NO UNPLANNE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519444 ↗
• InjuryDec 26, 2019Break

  IT WAS REPORTED DURING AN ACL RECONSTRUCTION WITH MENISCAL REPAIR PROCEDURE, A QUANTITY TWO AR-4570 FIBERSTITCH IMPLANTS FROM LOT: 19K24 WERE IMPLANTED SUCCESSFULLY. UPON TRYING TO INSERT THE THIRD AR-4570 (LOT: 19K24), THE TIP OF THE DEVICE BROKE. THE BROKEN TIP WAS FULLY RETRIEVED AND REMOVED FROM THE PATIENT BY USING A GRASPER. A FOURTH AR-4570 FROM THE SAME LOT WAS THEN BROUGHT IN. THE FIRST IMPLANT DEPLOYED AND IMPLANTED FINE. THE SURGEON THEN ATTEMPTED TO IMPLANT THE SECOND IMPLANT, BUT UPON REMOVING THE DEVICE FROM THE JOINT THE SECOND IMPLANT CAME OUT WITH THE DEVICE. THE SURGEON CUT THE SUTURE OF THE FIRST IMPLANT THAT WAS IN THE PATIENT, AND ALL PORTIONS OF THE FIRST IMPLANT WAS REMOVED FROM THE JOINT. THE REP STATED THE KNEE WAS VERY TIGHT, AND IT WAS VERY DIFFICULT FOR THE SURGEON TO MOVE AROUND WITHIN THE JOINT. THE SURGEON SWITCHED TO ANOTHER MANUFACTURERS DEVICE TO CONTINUE THE PROCEDURE. HOWEVER, THE SURGEON WAS STILL HAVING ISSUES WITH REPAIRING THE MENISCUS. THE SURGEON SWITCHED TO MENISCECTOMY, AND REMOVED A PORTION OF THE MENISCUS TO COMPLETE THE CASE. THE FIRST BROKEN AR-4570 AND RETRIEVED TIP WILL BE RETURNING FOR EVALUATION. THE SALES REP REPORTED NO UNPLANNE

  Patient problems: Failure of Implant

  MAUDE report 9519433 ↗