Arthrex® AR-8917DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867048959), received between Jun 19, 2018 and Aug 7, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16, 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.

• MalfunctionAug 7, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50177646 ↗
• MalfunctionDec 26, 2025Break; Break

  ON 04-DEC-2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THE TIP OF THE DRIVER BROKE WHILE INSERTING THE SCREW OF AN AR-8917DS MINI TIGHTROPE FT INTO AN INTERMEDIATE WEDGE-SHAPED BONE HOLE. THE SCREW WAS SUCCESSFULLY PLACED, AND ALL BROKEN FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-8917DS MINI TIGHTROPE FT. THE EVENT OCCURRED DURING A PROCEDURE ON (B)(6) 2025. NO DETAILED INFORMATION WAS PROVIDED REGARDING THE TYPE OF SURGERY. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO ADVERSE EFFECTS REPORTED. NO PHOTOS WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896121 ↗
• MalfunctionJan 10, 2025Break; Break

  ON (B)(6) 2024, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8917DS MINI TIGHTROPE FT THREAD BROKE WHEN TRYING TO SUTURE. THE CASE WAS COMPLETED USING ANOTHER MINI TIGHTROPE FT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. THERE WAS NO HARM TO THE PATIENT. REQUESTED ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED ON 12/20/2024: THIS WAS DISCOVERED DURING A LISFRANC PROCEDURE. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125137 ↗
• MalfunctionSep 17, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8917DS MINI TIGHTROPE FT SUTURE BROKE WHEN LIGATING THE THREATS AFTER IT WAS IMPLANTED. NO STRONG FORCE WAS USED. THE CASE WAS COMPLETED USING ANOTHER MINI TIGHTROPE FT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 9/9/2024: THIS WAS DISCOVERED DURING A LISFRANC PROCEDURE. EVERYTHING WAS REMOVED FROM THE PATIENT. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238298 ↗
• MalfunctionJul 9, 2024Break; Break

  ON 06/13/2024 IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA E-MAIL THAT AN AR-8917DS 3.5 MM MINI TIGHTROPE¿ FT BROKE AT THE BUTTON. THIS OCCURRED DURING A CASE ON A LISFRANC JOINT OF A FOOT. THE TECHNIQUE WENT WITHOUT ANY PROBLEMS, BUT WHEN A SURGEON TIGHTENED THE FINAL TENSION, THE FW BROKE AT THE BUTTON. HE REMOVED THE BUTTON AND SCREW. ADDITIONAL INFORMATION RECEIVED ON 6/20/2024: ALL THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. AFTER THE AR-8917DS 3.5 MM MINI TIGHTROPE FAILED, THE SURGEON DID NOT USE ADDITIONAL PRODUCTS, AS IT WAS DETERMINED THAT THE FIXING FORCE WAS SUFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700037 ↗
• MalfunctionJun 3, 2024Break; Break

  ON 4/12/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8917DS MINI TIGHTROPE KIT SUTURES HAVE SOME WEAR AND WHEN TYING THE KNOTS ON THE BUTTONS, THE SUTURES BROKE AND BUTTON COULD NOT BE FIXED. THIS WAS DISCOVERED AFTER IMPLANTING THE ANCHOR AND REMOVING THE INSERTER SHAFT DURING A LISFRANC LESION REPAIR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 4/18/2022: AFTER THE SUTURES BROKE, THE ANCHOR REMAIN IN THE PATIENT AND ALL SUTURE FRAGMENTS WERE REMOVED. CASE WAS COMPLETED USING AN AR-8911DS MINI TIGHTROPE REPAIR KIT FROM LOT NUMBER 14496584.

  Patient problems: Insufficient Information

  MAUDE report 19448809 ↗
• MalfunctionJan 22, 2024Break; Break

  ON 1/16/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-8917DS MINI TIGHTROPE FT SUTURE BROKE WHEN BEING LIGATED. ALL THE BROKEN SUTURES WERE REMOVED, AND CASE WAS COMPLETED WITH THE AR-8913DSMINI TIGHTROPE WITH INSERTER KIT THAT WAS IMPLANTED PRIOR TO THE AR-8917DS MINI TIGHTROPE FT. THIS WAS DISCOVERED DURING A LISFRANC LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 1/17/2023: BOTH ANCHORS WERE REMOVED ALONG WITH THE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 18555411 ↗
• MalfunctionJan 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A HALLUX VALGUS CORRECTION SURGERY THE ANCHOR TORE OUT OF THE BONE. AFTER THE SURGEON WAS ABLE TO FIXATE THE IMPLANT ON THE METATARSAL THE BUTTON BECAME LOOSE. THE SURGEON WAS ABLE TO RETRIEVE THE BUTTON AND THE SUTURES BUT THE ANCHOR REMAINED INSIDE THE PATIENT. THE SURGEON WAS FINISHED WITH A DIFFERENT DEVICE WHICH WAS PLACED MORE DISTAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 18456620 ↗
• InjuryMay 20, 2020Break

  IT WAS REPORTED THAT THE MINI TIGHTROPE, AR-8917DS, WAS BEING USED IN A LISFRAC JOINT DISLOCATION REPAIR PROCEDURE. DURING USE, THE SUTURE BROKE. FURTHERMORE, WHEN ATTEMPTING TO REMOVE THE REMAINING SCREW, IT WAS CONFIRMED THAT THE TIP OF THE INSERTER WAS BROKEN AND THE BROKEN PIECE WAS IN THE HEAD OF THE SCREW. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 05/05/2020: THE SCREW WAS LEFT IN THE PATIENT WITH THE TIP OF THE DRIVER LODGED IN THE HEAD OF THE SCREW. THERE ARE NO X-RAYS AVAILABLE AND THE INSERTER WILL BE RETURNED FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10074777 ↗
• InjuryApr 22, 2019Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2019 WHERE AN ARTHREX MINI TIGHTROPE, AR-8917DS, WAS IMPLANTED WITH NO ISSUE. AFTER THE CASE, THE SURGEON TOOK AN X-RAY AND IT WAS FOUND THAT THE TIP OF THE DRIVER HAD BROKEN OFF INTO THE IMPLANT AND WAS STILL ATTACHED. A SECOND SURGERY WAS PERFORMED AND THE BROKEN DRIVER TIP WAS REMOVED STILL FUSED TO THE SCREW. THEY WERE BOTH REMOVED WITH NO INCIDENT. A SECOND SCREW WAS OPENED AND USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE ARTHREX REP THAT WAS PRESENT DURING THE LISFRANC LIGAMENT REPAIR AND CONFIRMED THAT A SECOND SURGERY WAS NOT NECESSARY AS PREVIOUSLY REPORTED. THE IMPLANT WAS REMOVED DURING THE SAME SURGERY. IT IS NOT CLEAR TO THE SURGEON WHEN THE DRIVER BROKE. THE SURGEON NOTICED THAT IT WAS BROKEN AT THE TIME OF THE X-RAY. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE SURGEON REOPENED INCISIONS TO REMOVE THE IMPLANT; HE DID NOT HAVE TO CREATE ANY NEW INCISIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535437 ↗
• InjuryApr 10, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LISFRANC LIGAMENT REPAIR PROCEDURE, WHILE SCREWING IN THE IMPLANT, THE TIP OF THE DRIVER INCLUDED IN THE AR-8917DS, LOT NUMBER 10198981, BROKE OFF INTO THE PATIENT. THE SURGEON DID NOT RETRIEVE THE BROKEN PIECES, THINKING THAT THERE WAS NO PROBLEM. BEFORE THE OPERATION, THE RISK OF TIP BREAKING WAS EXPLAINED. DURING THE OPERATION, THE SURGEON USED 3 FINGERS TO HOLD THE DRIVER AND INSERTED IT. SURGEON STATED THAT THE PATIENT'S BONY TISSUE WAS HARD. ADDITIONAL INFORMATION PROVIDED 4/1/2019: THE TIP OF THE DRIVER BROKE OFF INTO THE IMPLANT. THE SURGEON USED THE SAME DRIVER TO COMPLETE THE CASE. NO X-RAYS WERE TAKEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8500687 ↗
• InjuryJun 19, 2018Difficult to Remove; Failure to Advance; Positioning Problem

  IT WAS REPORTED THAT DURING A LISFRANC TIGHTROPE FIXATION PROCEDURE, UPON INSERTION OF THE ANCHOR, THE SCREW DRIVER HEAD BECAME STRIPPED. THE ANCHOR COULD NOT BE REMOVED, NOR COULD IT BE ADVANCED. THE SURGEON THEN OPENED A SECOND KIT IN AN ATTEMPT TO USE ITS DRIVER TO INSERT THE ANCHOR FURTHER INTO THE BONE OR BACK IT OUT OF THE BONE BUT THE ATTEMPT WAS UNSUCCESSFUL. HE SHAVED THE BONE AROUND THE ANCHOR TO RETRIEVE IT. THE SURGEON USED A CANNULATED CANCELLOUS SCREW TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7614179 ↗