Arthrex® AR-8862DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867288263), received between Mar 21, 2019 and Jul 7, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Break; Break

  ON 6/10/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT FOLLOWING THE USE OF THE AR-8862DS PARS SUTURETAPE IMPLANT SYSTEM TO REPAIR AN ACHILLES TENDON RUPTURE, THREE SUTURES RUPTURED DURING A DORSIFLEXION TEST INTENDED TO CONFIRM THE INTEGRITY OF THE REPAIR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE AR-7500 SYSTEM. THERE WAS NO HARM TO THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22415272 ↗
• MalfunctionNov 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 10/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE GREEN FIBERLINK SUTURES FROM AN AR-8862DS PARS SUTURETAPE IMPLANT SYSTEM WERE RIPPED AND WERE NOT ABLE TO COMPLETE THE LOCKING STITCH. A SECOND KIT WAS OPENED TO COMPLETE THE CASE. THE CASE WAS DELAYED ABOUT FIVE MINUTES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611842 ↗
• MalfunctionMay 23, 2024Break; Break

  ON 03/18/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8862DS PARS SUTURETAPE IMPLANT SYSTEM, TWO SUTURETAPES BROKE. AFTER TYING EACH SET OF SUTURES, SURGEON DORSIFLEXED THE FOOT TO TEST THE INTEGRITY OF THE REPAIR WHEN A "POP" SOUND WAS HEARD. INITIALLY IT THOUGHT THE SUTURE KNOTS CAME UNDONE, BUT AFTER FURTHER INSPECTION, IT WAS REALIZED THAT TWO OF THE SUTURETAPES SNAPPED ABOUT 10MM ABOVE WHERE THE KNOTS WERE TIED. THERE WAS NO FRAYING OF THE SUTURETAPE. THIS WAS DISCOVERED DURING AN END TO END PARS PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED 3/21/2021: ALL THE BROKEN SUTURES WERE REMOVED FROM INSIDE THE PATIENT AND CASE WAS COMPLETED WITH A NEW PARS SUTURETAPE KIT FROM THE SAME LOT NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 19384984 ↗
• MalfunctionOct 26, 2023Component Missing; Component Missing

  ON 9/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8862DS PARS SUTURETAPE IMPLANT SYSTEM HAD WHITE/BLACK SUTURETAPES IN SPOTS THREE AND FOUR INSTEAD OF THE GREEN FIBERLINKS. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A PARS ACHILLES REPAIR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED BY OPENING TWO INDIVIDUALS FIBERLINKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011657 ↗
• InjuryDec 7, 2022Break

  ON 11/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A SUTURETAPE #2 AND SUTURETAPE #5 FROM AN AR-8862DS PARS SUTURETAPE IMPLANT SYSTEM, RUPTURED AT THE KNOT SITE WHILE ATTEMPTING TO TIE THEM BY HAND. IN ORDER TO REMOVE THE BROKEN SUTURES, SURGEON OPENED THE INCISION LARGER. THIS WAS DISCOVERED DURING AN ACHILLES TENDON REPAIR PROCEDURE ON (B)(6) 2022.

  Patient problems: Laceration(s)

  MAUDE report 15931052 ↗
• InjuryMay 3, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8862DS PARS SUTURETAPE KIT KEPT FAILING. THE SUTURES WOULD NOT HOLD AND SURGEON HAS TO MAKE A LARGER INCISION TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. AT FIRST, CASE WAS A PARS ACHILLES REPAIR BUT DUE TO DEVICE FAILURE, SURGEON ENDED UP PERFORMING AN OPEN ACHILLES REPAIR.

  Patient problems: Laceration(s)

  MAUDE report 14269868 ↗
• MalfunctionAug 7, 2020Break

  AN ARTHREX EMPLOYEE HAS REPORTED THAT THE TAPES DID NOT HOLD INTRA OPERATIVE AFTER MINIMAL LOAD. ALL KNOTS OPENED VERY EASILY AFTER FIVE STROKES. THE SURGEON NEEDED TO CHANGE THE SURGICAL TECHNIQUE FROM PARS TO KRAKOW SEAM. THE SURGERY COULD NOT BE COMPLETED IN A MINIMALLY INVASIVE MANNER, A LARGER INCISION HAD TO BE MADE AND AN OPEN SUTURE TECHNIQUE USED TO FINISH THE SURGERY SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 10379004 ↗
• InjuryMar 21, 2019Material Protrusion/Extrusion

  ORIGINAL DATE OF SURGERY (B)(6) 2019. MID SUBSTANCE ACHILLES RUPTURE. THE SURGEON STATES THAT THE SUTURES ARE COMING OUT AT THE SITE. HE WANTED THE REP TO INQUIRE IF WE HAVE HAD PREVIOUS INSTANCES OF THIS. REP IS UNSURE WHAT THE SURGEON WILL BE DOING ABOUT THIS. PATIENT IS MALE, UNKNOWN AGE. ADDITIONAL INFORMATION OBTAINED 3/7/2019: THE PATIENT UNDERWENT A PARS MID-SUBSTANCE REPAIR PROCEDURE. THE INCISION HEALED AND THE SUTURES BEGAN TO PROTRUDE THROUGH THE PATIENT'S SKIN AT THE DISTAL ANCHOR SITE. THE SURGEON HAS PERFORMED A REVISION PROCEDURE TO REMOVE THE ANCHORS AND THE CONNECTED SUTURE FROM THE PATIENT. THE SURGEON FOUND THE ACHILLES LOOKS GOOD AFTER THE REPAIR. PATIENT HAS NO KNOWN ALLERGIES AND IS NOT DIABETIC. NO PHOTOS WERE AVAILABLE TO PROVIDE. SALES REP STATED THE SURGEON INDICATED TO HIM THAT HE BELIEVES THERE IS SOME SORT OF INFLAMMATORY RESPONSE TO THE ANCHORS, AS THE WOUND INITIALLY HEALED AND THEN APPEARED TO BECOME FULL OF PUS AND IS SOFT TO THE TOUCH BEFORE IT OPENED UP AND BEGAN TO SPIT OUT THE SUTURE. DATE OF REVISION IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION OBTAINED 3/21/19: THE SURGEON HAS PERSONALLY PROVIDED CORRECTED SURGERIES DATES. ORIGINAL DATE OF

  Patient problems: Fluid Discharge; Inflammation

  MAUDE report 8440494 ↗