Arthrex® AR-8860JRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867048621), received between May 4, 2017 and Dec 22, 2025 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Use of Device Problem; Use of Device Problem

  ON 12/01/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) AND PHONE THAT AN AR-8860J JIG PARS MISSED THE INNER TINES. THIS EVENT OCCURRED DURING AN ACHILLES RUPTURE REPAIR. THE ISSUE OCCURRED WHEN THE DEVICE¿S INNER TINES WERE LOOSE, CAUSING THE PASSER TO MISS THE ACHILLES TENDON. THE CASE WAS COMPLETED BY EXTENDING THE INCISION AND USING A TRADITIONAL STITCH.

  Patient problems: Insufficient Information

  MAUDE report 23864417 ↗
• MalfunctionAug 20, 2025Failure to Align; Failure to Align

  ON 08/05/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) 1THAT AN AR-8860J JIG WAS USED IN SURGERY FOR AN ACHILLES TENDON RUPTURE. AFTER INSERTION INTO THE BODY, INTERFERENCE WITH THE DEVICE OCCURRED WHEN INSERTING THE PASSING NEEDLE. AN ATTEMPT WAS MADE TO PASS THE NEEDLE BY CHANGING THE HAND, BUT IT ENDED UP OUTSIDE THE WINDOW FRAME ON THE OTHER SIDE. ONCE THE DEVICE WAS REMOVED FROM THE BODY AND CHECKED, IT WAS NOTED THAT THE MIDDLE WINDOW THROUGH WHICH THE NEEDLE PASSES WAS NOT PARALLEL. AS THE NUT WAS TIGHTENED, MISALIGNMENT OCCURRED, AND SINCE IT MAINTAINED PARALLELISM WHEN FULLY OPENED, THE NEEDLE WAS PASSED IN THAT STATE. AFTER SEVERAL REPEATED MISALIGNMENTS, TAPE PASSING INTO THE ACHILLES TENDON WAS COMPLETED. WHEN THE DEVICE WAS CHECKED AFTER SURGERY, RATTLE WAS FOUND ON ONLY ONE SIDE OF THE DEVICE'S MIDDLE WINDOW. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852494 ↗
• InjuryAug 12, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8860J JIG, PARS CENTRAL TONGS OF THE JIG WERE DEVIATING/JIGGLING AND WERE UNABLE TO BE TIGHTENED OR ADJUSTED TO PREVENT THIS. THE SURGEON ATTEMPTED TO MANIPULATE THE JIG AND ADJUST THE KNOBS/SCREWS/DIALS THAT THE PARS JIG HAS TO PREVENT THE TONGS/ARMS FROM MOVING, BUT THIS DID NOT FIX THE ISSUE. THE SURGEON HAD TO OPEN THE PROCEDURE AND BAIL OUT TO A DIFFERENT PLAN. IN ORDER TO COMPLETE THE PROCEDURE, THE SURGEON OPENED THE INCISION FURTHER AND USED KRAKOW STITCHES TO BRING THE ACHILLES TENDON TOGETHER. THIS WAS DISCOVERED DURING A PARS ACHILLES RUPTURE REPAIR. THE CASE WAS COMPLETE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781730 ↗
• MalfunctionJun 20, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 05/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8860J JIG, PARS ALIGNMENT WAS OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298160 ↗
• MalfunctionFeb 13, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  ON 01/23/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-8860J JIG CENTER TINES WERE NOT STURDY AND WERE WOBBLING. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374087 ↗
• MalfunctionNov 15, 2024Defective Device; Defective Device

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8860J JIG IS MALFUNCTIONING. CONTACT TRIED PASSING THROUGH THE JIG SIX TIMES AND IT MISSED THE INNER ARMS EVERY TIME. THEY COULDN'T GET ALL THE SUTURES IN AND HAD TO CHANGE THE APPROACH. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694772 ↗
• MalfunctionNov 11, 2024Fitting Problem; Fitting Problem

  ON 10/31/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN AR-8860J JIG WAS MALFUNCTIONING. THEY TRIED PASSING THROUGH THE JIG SIX TIMES, AND IT MISSED THE INNER ARMS EVERY TIME. THEY COULD NOT GET ALL THE SUTURES IN AND HAD TO CHANGE THE APPROACH. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651889 ↗
• MalfunctionNov 7, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8860J PARS JIG WAS BENT AND MISSING THE MEDIAL FORK OF THE GUIDE, MAKING SUTURES DIFFICULT TO PASS. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY WHILE USING THESE INSTRUMENTS BUT ARE NOT WORKING WELL ENOUGH TO BE USED IN ANOTHER SURGERY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634661 ↗
• MalfunctionOct 24, 2024Positioning Failure; Defective Device; Positioning Failure; Defective Device

  ON 10/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8860J JIG, PARS WAS NOT OPERATING CORRECTLY; THE NEEDLES COULD BARELY FIT THROUGH THE HOLES (SEE VIDEO ATTACHMENT). THE SURGEON HAD TO MALLET THE NEEDLES TO BE ABLE TO GET THEM TO PASS THROUGH THE JIG. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525964 ↗
• InjuryMay 31, 2023Capturing Problem; Capturing Problem

  ON 05/08/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8860J JIG TINES ARE LOOSE. "DURING THE PROCEDURE 2 OF THE SUTURES MISSED THE PARS JIG LEADING TO AN EXTENSION OF THE INCISION AND DEFEATING THE PURPOSE OF THIS MINIMALLY INVASIVE PROCEDURE. UPON FURTHER INSPECTION OF THE INSTRUMENT, THE INNER TINES OF THE PARS JIG WERE FOUND TO BE LOOSE LEADING TO A MISSED CAPTURE IN THE 3RD AND 4TH SUTURE OF THE SEQUENCE. WE WERE NOT ABLE TO CHARGE THE FACILITY FOR AR-8862DS (PARS SUTURETAPE IMPLANT SYSTEM) DUE TO THIS EVENT.". THIS WAS DISCOVERED DURING A CASE, SURGEON HAD TO DIVERT FROM INTENDED PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031481 ↗
• MalfunctionSep 14, 2021Mechanical Problem; Difficult to Advance

  ON 08/24/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8860J PARS JIG WAS NOT PASSING NEEDLES CORRECTLY. THE DEVICE WAS HITTING THE INSIDE PRONGS KEEPING THE SURGEON FROM PASSING SUTURE CORRECTLY. THIS WAS DISCOVERED DURING USE IN AN ACHILLES REPAIR ON 8/24/2021. ALL TIPS AND PEARLS WERE PERFORMED DURING THE PROCEDURE THE CASE WAS COMPLETED BY DOING AN OPEN REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 12467496 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP, THAT DURING AN ACHILLES RUPTURE PROCEDURE, THE SURGEON PLACED THE PARS JIG, AR-8860J, INTO THE PATIENT KNOWING THAT THE PINS WERE LOOSE. AFTER THE PINS WERE PLACED THE SURGEON COULD NOT PASS THE SUTURES IN THE ORDER AS INDICATED ON THE CARD. THE # 1 AND # 5 SUTURES HAD TO BE SWITCHED. THE CASE WAS COMPLETED. ADDITIONAL INFORMATION PROVIDED 11/21/2019: THE CASE TOOK PLACE ON (B)(6) 2019. AFTER REMOVAL OF THE JIG, THE SUTURES PULLED THROUGH SO THE SURGEON SWITCHED THE BLACK AND WHITE SUTURE ORDER. THE CASE TOOK LONGER THAN NORMAL AS THE REP WAS TROUBLESHOOTING THE JIG AND THE PATIENT WAS ADMINISTERED ADDITIONAL ANESTHESIA. ADDITIONAL INFORMATION 11-25-2019: PER THE SALES REP, THE SURGERY WAS EXTENDED FOR 45 MINUTES. THERE WERE NO UNPLANNED INCISIONS. THE SURGEON USED OPEN KRACKOW TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 9443498 ↗
• InjuryMay 4, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A MID-SUBSTANCE ACHILLES RUPTURE CASE, ONCE THE NEEDLE WAS PASSED THROUGH THE PERCUTANEOUS TISSUE, THE SURGEON COULD NOT GET IT TO CATCH IN THE ARMS OF THE PARS JIG. HE HAD TO CONVERT FROM A TRANSVERSE INCISION TO A LINEAR INCISION AND USED A #5 ETHIBOND TO COMPLETE THE SURGERY. IT CAUSED A DELAY OF 30-60 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6544168 ↗