Arthrex® AR-2270Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867026599), received between Jun 14, 2018 and Jan 30, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT THAT "THEY HAD THE DOG BONE BUTTON SURGERY RECENTLY HOWEVER, SOMETHING WENT WRONG, AND THEY ARE BACK TO A DISPLACEMENT AT THE AC JOINT." NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Joint Dislocation

  MAUDE report 18607692 ↗
• MalfunctionJul 3, 2023Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device

  06/09/2023, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE EVENT OCCURRED ON JUNE 1 DURING AN AC JOINT RECON CASE. THE PRODUCT WAS DISCARDED AND REPLACED WITH A NEW ONE WITH DIFFERENT LOT NUMBER. NO PHOTOS/VIDEOS CAPTURED.

  Patient problems: Insufficient Information

  MAUDE report 17247295 ↗
• InjuryMar 30, 2021Device Dislodged or Dislocated; Separation Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN AC SEPARATION THAT WAS INITIALLY TREATED WITH THE AR-2270 DOG BONE IMPLANT. A FEW WEEKS LATER, THE ANCHOR IN THE COROCOID HAD PULLED OUT AND WAS REVISED USING A CLAVICLE HOOK PLATE.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 11591179 ↗
• InjuryJul 22, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A REVISION ACL PROCEDURE ON (B)(6) 2020. 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: 1913080-1009. 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: 1059114

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

  MAUDE report 10308386 ↗
• InjuryJan 27, 2020Break; Therapeutic or Diagnostic Output Failure; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE FOLLOWING CLINICAL EVENT INFORMATION WAS PROVIDED IN A TGA CLOSURE LETTER: PATIENT UNDERWENT A SHOULDER SURGERY ON (B)(6) 2019 USING X4 ARTHREX TIGHTROPE ABS IMPLANTS, AR-1588TN, (ARTG ID# (B)(4)). THE PATIENT WAS TOLD BY HIS ORTHOPEDIC SURGEON EACH ONE HAS 1000 NEWTONS STRENGTH (102 KG FORCE) BEING 408 KG FORCE TOTAL TO BREAK. PATIENT STATES HE KNOWS EVERYTHING LOOKED WELL THE MORNING AFTER SURGERY BECAUSE X-RAYS WERE TAKEN. AFTER SEVERAL WEEKS WHEN HE CAME OUT OF SLING HE NOTICED THE CLAVICLE STILL STUCK UP LIKE BEFORE SURGERY. HE WENT TO HIS GENERAL PRACTITIONER WHO SENT HIM FOR AN X-RAY ON (B)(6) 2019 WHICH SHOWED SEPARATION WITH ANCHORS STILL PROPERLY PLACED. THE PATIENT THEN SAW HIS ORTHOPEDIC SURGEON WHO CONFIRMED IT LOOKS LIKE THE PRODUCT HAS FAILED. THE PATIENT HAS A REVISION SURGERY SCHEDULED FOR REPLACEMENT OF THE PRODUCT. ADDITIONAL INFORMATION PROVIDED 9/6/2019- THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2019. THE DOGBONE UNDER THE CLAVICLE WILL REMAIN IN THE PATIENT AS IT IS TOO DANGEROUS TO REMOVE. THE PATIENT DID NOT SUFFER ANY KIND OF POST-OP TRAUMA. ADDITIONAL INFORMATION PROVIDED 1/7/2020- THE PRODUCT SPECIALIST SPOKE TO THE HOSPITAL AN

  Patient problems: No Information

  MAUDE report 9631341 ↗
• InjuryJan 27, 2020Material Separation

  IT WAS REPORTED THAT THE FOLLOWING CLINICAL EVENT INFORMATION WAS PROVIDED IN A TGA CLOSURE LETTER: PATIENT UNDERWENT A SHOULDER SURGERY ON (B)(6) 2019 USING X4 ARTHREX TIGHTROPE ABS IMPLANTS, AR-1588TN, (ARTG ID# (B)(4)). THE PATIENT WAS TOLD BY HIS ORTHOPEDIC SURGEON EACH ONE HAS 1000 NEWTONS STRENGTH (102 KG FORCE) BEING 408 KG FORCE TOTAL TO BREAK. PATIENT STATES HE KNOWS EVERYTHING LOOKED WELL THE MORNING AFTER SURGERY BECAUSE X-RAYS WERE TAKEN. AFTER SEVERAL WEEKS WHEN HE CAME OUT OF SLING HE NOTICED THE CLAVICLE STILL STUCK UP LIKE BEFORE SURGERY. HE WENT TO HIS GENERAL PRACTITIONER WHO SENT HIM FOR AN X-RAY ON (B)(6) 2019 WHICH SHOWED SEPARATION WITH ANCHORS STILL PROPERLY PLACED. THE PATIENT THEN SAW HIS ORTHOPEDIC SURGEON WHO CONFIRMED IT LOOKS LIKE THE PRODUCT HAS FAILED. THE PATIENT HAS A REVISION SURGERY SCHEDULED FOR REPLACEMENT OF THE PRODUCT. ADDITIONAL INFORMATION PROVIDED 9/6/2019- THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2019. THE DOGBONE UNDER THE CLAVICLE WILL REMAIN IN THE PATIENT AS IT IS TOO DANGEROUS TO REMOVE. THE PATIENT DID NOT SUFFER ANY KIND OF POST-OP TRAUMA. ADDITIONAL INFORMATION PROVIDED 1/7/2020- THE PRODUCT SPECIALIST SPOKE TO THE HOSPITAL AN

  Patient problems: Failure of Implant

  MAUDE report 9631332 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem

  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: Autoimmune Disorder; Pain; Swelling

  MAUDE report 7600210 ↗