Arthrex® AR-1588TN-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867019713), received between Jun 14, 2018 and Jul 24, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Defective Device; Defective Device

  ADDITIONAL INFORMATION RECEIVED ON 7/24/2024: THIS WAS DISCOVERED ON THE BACK TABLE DURING AN ALLOGRAFT ACL RECONSTRUCTION WITH QUADLINK PROCEDURE. THE TIGHTROPE DIDN'T CONVERT CORRECTLY. ONE-HALF OF THE TIGHTROPE WOULD NOT LOOSEN OR TIGHTEN, IT WAS JUST A CONTINUOUS LOOP THAT WOULD SLIDE. BOTH TIGHTROPES DID THE EXACT SAME THING. NOTHING BROKE IN THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-1588TN-1 TIGHTROPE ABS. THE CASE WAS DELAYED APPROXIMATELY TWENTY MINUTES; HOWEVER, IT'S UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

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

  MAUDE report 19817607 ↗
• MalfunctionJul 24, 2024Defective Device; Defective Device

  ADDITIONAL INFORMATION RECEIVED ON 7/24/2024: THIS WAS DISCOVERED ON THE BACK TABLE DURING AN ALLOGRAFT ACL RECONSTRUCTION WITH QUADLINK PROCEDURE. THE TIGHTROPE DIDN'T CONVERT CORRECTLY. ONE-HALF OF THE TIGHTROPE WOULD NOT LOOSEN OR TIGHTEN, IT WAS JUST A CONTINUOUS LOOP THAT WOULD SLIDE. BOTH TIGHTROPES DID THE EXACT SAME THING. NOTHING BROKE IN THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-1588TN-1 TIGHTROPE ABS. THE CASE WAS DELAYED APPROXIMATELY TWENTY MINUTES; HOWEVER, IT'S UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

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

  MAUDE report 19817606 ↗
• MalfunctionMay 10, 2024Failure to Advance; Failure to Advance

  ON 12/23/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TN-1 TIGHTROPE ABS AND AN AR-1588BTB-IB TIGHTROPE II BTB MECHANISMS WOULD NOT PROPERLY SLIDE THROUGH THE GRAFT. CASE WAS COMPLETED BY CUTTING THE TIGHTROPES AND USING AN AR-4030C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285979 ↗
• InjuryJul 22, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A REVISION ACL PROCEDURE ON 6/12/20. DURING THE PROCEDURE A LIFENET FGL WAS USED. PATIENT HAD DEVELOPED AN INFECTION. SURGEON WASHED OUT THE KNEE. SO FAR NOTHING HAS GROWN ON CULTURES, BUT HE WILL HAVE TO TAKE THE ALLOGRAFT OUT IF THE PATIENT DOESN¿T GET BETTER. THE REPORTER ALSO COPIED LIFENET IN ON THEIR INITIAL REPORT TO ARTHREX. GRAFT ID: (B)(4). ADDITIONAL INFORMATION PROVIDED ON 7/8/2020: THE PHYSICIAN REPORTED THE PATIENT HAD A PRIOR ACL SURGERY MANY YEARS AGO (>7) AND A REVISION WAS PERFORMED ON (B)(6) 2020. NO EVIDENCE OF ANY PRIOR OSTEO OR INFECTION IN THE PAST. THE PRIMARY SURGERY WAS PERFORMED BY A DIFFERENT SURGEON. THE SURGEON CANNOT CONFIRM IF ARTHREX PRODUCTS WERE USED DURING THE PRIMARY PROCEDURE. THE PATIENT DECIDED TO HAVE IT FINALLY REVISED, BUT HAD BEEN LIVING WITHOUT THEIR ACL FOR AWHILE. THE INDEX REVISION ACL SURGERY WAS ON (B)(6) 2020. WASHOUT WAS PERFORMED ONE WEEK LATER ON (B)(6) 2020. NO IMPLANTS WERE EXPLANTED AT THE TIME OF THE WASHOUT. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE REVISION SURGERY; FGL // GRAFT ID: 1913080-1009. AR-1588TN-1 // LOT: 10655198. AR-1588BTB // LOT: 10591147. AR-2270

  Patient problems: Fatigue; Fever; Pain; Pleural Effusion; Sweating; Unspecified Infection; Weight Changes

  MAUDE report 10308319 ↗
• InjuryJun 14, 2018Patient-Device Incompatibility

  IT WAS REPORTED BY A PATIENT THAT ON (B)(6) 2017 SHE HAD A PCL RECONSTRUCTION. DURING THAT PROCEDURE AN ARTHREX DOG BONE BUTTON, WAS IMPLANTED. THE PATIENT HAS BEEN EXPERIENCING AN ACHY PAIN AND SWELLING AT AND BELOW THE KNEE WHICH BEGAN RIGHT AFTER THE PROCEDURE AND HAS BEEN ONGOING. WHILE RECOVERING FROM THE PCL PROCEDURE THE PATIENT SUFFERED AN INJURY AND REQUIRED A DOUBLE MENISCUS TRANSPLANT WHICH TOOK PLACE ON (B)(6) 2017. THE ACHY PAIN AND SWELLING CONTINUED AFTER THE (B)(6) 2017 PROCEDURE AND STILL CONTINUES AT TIME OF THIS REPORT. PATIENT NOTES THAT SHE IS A RUNNER AND OVER THE YEARS HAS HAD A TOTAL OF SEVEN SURGERIES ON THIS KNEE. NO ISSUES OCCURRED AFTER ANY OF THE SURGERIES THAT TOOK PLACE PRIOR TO THE (B)(6) 2017 PCL PROCEDURE. IT HAS ONLY BEEN SINCE THAT PROCEDURE THAT SHE HAS HAD TO DEAL WITH THESE TYPES OF PROBLEMS. PATIENT ALSO NOTED THAT SHE HAS HAD PAST AUTO IMMUNE ISSUES IN HER LIFE AND WOULD LIKE TO RULE OUT ANY POSSIBILITY OF AN ALLERGIC REACTION TO THE ARTHREX IMPLANTS. PATIENT WILL OBTAIN THE FULL PART NUMBERS OF ALL IMPLANTS FROM (B)(6) 2017 PROCEDURE AS WELL AS ALL (B)(6) 2017 PROCEDURE IMPLANTS IF ANY. PATIENT IS REQUESTING MATERIAL COMPOSITION OF ALL ARTH

  Patient problems: Pain; Swelling

  MAUDE report 7600212 ↗