Arthrex® AR-8913DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867048874), received between Jun 1, 2021 and Sep 23, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  On 08-Sep-2026, a distributor reported via email that an AR-8913DS Mini TightRope with Inserter experienced a suture break during use. The issue was identified during a hand and wrist syndesmosis procedure performed on (b)(6)2026. An alternative implant was utilized to complete the procedure. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867358 ↗
• MalfunctionDec 9, 2024Break; Break

  ON 11/12/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8913DS MINI TIGHTROPE SUTURE BROKE. THIS WAS DISCOVERED DURING A LISFRANC PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER AR-8913DS MINI TIGHTROPE.

  Patient problems: Insufficient Information

  MAUDE report 20884794 ↗
• InjurySep 19, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8980BC DX KNOTLESS SWIVELOCK, AN AR-8913DS MINI TIGHTROPE, AND AN AR-7237-7 FIBERTAPE COULD NOT BE EASILY IMPLANTED. THE PATIENT'S BONE WAS HARD, SO THE SURGEON TAPPED THE IMPLANTS IN WITH A MALLET TO PLACE THEM IN THE TUNNEL. THIS WAS DISCOVERED DURING A LISFRANC PROCEDURE ON (B)(6) 2024. ONE TO TWO WEEKS LATER, ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE ALL THE PRODUCTS EXPLANTED. THE AR-8980BC DX KNOTLESS SWIVELOCK ANCHOR HAD PULLED OUT OF THE MEDIAL CUNEIFORM BONE. THE LISFRANC LIGAMENT PLASTY PROCEDURE WAS COMPLETED USING AN AR-8913DS MINI TIGHTROPE FROM LOT NUMBER 15242118, AN AR-7237-7 FIBERTAPE FROM LOT NUMBER 15081694, AND AN AR-8922 SUTURE BUTTON FROM LOT NUMBER 15166049.

  Patient problems: Failure of Implant

  MAUDE report 20257153 ↗
• MalfunctionSep 13, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8913DS MINI TIGHTROPE BUTTON DETACHED FROM THE INSERTER AND COULD NOT BE REINSTALLED. THIS WAS DISCOVERED DURING THE INSERTION OF THE IMPLANT DURING A PROCEDURE ON 8/28/2024. THE CASE WAS COMPLETED USING ANOTHER AR-8913DS MINI TIGHTROPE. ADDITIONAL INFORMATION RECEIVED ON 9/5/2024: THIS WAS DISCOVERED DURING A LISFRANC PROCEDURE. THE BUTTON DETACHED FROM THE INSERTER BUT WAS STILL ATTACHED BY THE SUTURES. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS NEEDED.

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

  MAUDE report 20212852 ↗
• MalfunctionJun 6, 2024Break; Break

  ON 3/6/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8913DS MINI TIGHTROPE SUTURES UNRAVELED AND BREAK DURING TENSIONING. DURING SURGERY, TWO INCISIONS ARE MADE, MAKING THE FIRST DORSAL APPROACH OVER THE ENTOCUNEIFORMS JOINT. THE SECOND APPROACH IS MADE ALONG THE MEDIAL CUNEIFORM. A REDUCTION CLAMP IS PLACED TO COMPRESS AND REDUCE THE BASE OF THE SECOND METATARSAL AND THE MEDIAL CUNEIFORM WHILE TRACTION IS APPLIED TO THE MEDIAL COLUMN. THE MEDIAL STARTING POINT OF THE 1.2MM GUIDEWIRE IS LOCATED ON THE MEDIAL CUNEIFORM DISTAL TO THE ANTERIOR TIBIALIS INSERTION IN THE MIDCORONAL PLANE. THE GUIDEWIRE IS DIRECTED, ASSISTED BY FLUOROSCOPY, TOWARD THE BASE OF THE SECOND METATARSAL IN THE MIDCORONAL PLANE, DISTAL TO THE SECOND TMT JOINT, BETWEEN THE SECOND AND THIRD METATARSALS. THE 2.7 MM CANNULATED DRILL IS ADVANCED OVER THE GUIDEWIRE. THE MINI TIGHTROPE WITH HANDLED INSERTER IS PASSED FROM MEDIAL TO LATERAL. THE BUTTON IS FLUSH WITH THE LATERAL CORTEX OF THE SECOND METATARSAL BASE. WHEN STARTING THE ADJUSTMENT OF THE MINI TIGHTROPE BY PULLING THE FREE SUTURES, THEY UNRAVEL, BREAKING WITHOUT BEING ABLE TO FINISH THE ADJUSTMENT AND FIXATION OF THE BUTTON. A SECOND AR-8913DS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480278 ↗
• MalfunctionMay 2, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS (B)(4) THAT AN AR-8913DS DRILL TIP BROKE WHEN IT WAS DRILLING WITH THE 2.7MM HOLLOW DRILL INCLUDED IN THE KIT. ALL FRAGMENTS WERE REMOVED AND THERE WAS NO IMPACT TO THE PATIENT. THE SURGERY WAS COMPLETED USING THE SAME PRODUCT FROM A NEW KIT WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229637 ↗
• MalfunctionDec 8, 2023Break; Break

  ON 1/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8913DS MINI TIGHTROPE INSERTER SHAFT'S SUTURES WERE UNBUTTONED AND SURGEON HAD TO REATTACH THEM IN ORDER TO BE USED. DURING THE PROCEDURE, SURGEON WAS APPLYING TENSION TO THE SUTURES AND THE BROKE OFF. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022 ADDITIONAL INFORMATION RECEIVED 1/21/2022: THIS WAS DISCOVERED DURING A LISFRANC LIGAMENT INJURY PROCEDURE. SURGEON REMOVED ALL THE BROKEN SUTURES FROM INSIDE THE PATIENT AND WAS ABLE TO COMPLETE THE CASE USING ANOTHER AR-8913DS FROM LOT NUMBER 13635602.

  Patient problems: Insufficient Information

  MAUDE report 18297165 ↗
• MalfunctionOct 12, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT THE SUTURES FROM AN AR-8913DS MINI TIGHTROPE WITH INSERTER BROKE. THE END OF THE SUTURES WAS PULLED BACK TOGETHER WITH A NUMBER TWO FIBERWIRE SUTURE. THIS WAS DISCOVERED DURING A LISFRANC PROCEDURE ON (B)(6) 2023. THE REMAINDER OF THE BROKEN SUTURE WAS REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 17920448 ↗
• MalfunctionJun 1, 2021Activation, Positioning or Separation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE USING AN AR-8913DS DRIVER, THE SHAFT DID NOT EASILY ENTER THE BONE HOLE, AND THE BUTTON DID NOT COME OFF FROM THE HANDLE. THE SURGEON RELEASED THE BUTTON BY USING FORCEPS, THE BUTTON CAME OUT OF THE BONE HOLE. THE SURGEON REVIEWED THE SURGICAL KIT, HE FOUND THAT THE INSERTER WAS BENT. THE DOCTOR IN CHARGE SUSPECTS THAT BONE HOLE WAS ENLARGED. THE SURGERY WAS COMPLETED BY A NEW PRODUCT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912152 ↗