Arthrex® AR-8740-40PTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867046443), received between Oct 1, 2018 and Mar 17, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2023Break; Break

  ON 2/28/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8740-40PTS LOW PROFILE SCREW SHEERED AND BROKE IN HALF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A CALCANEUS FRACTURE PROCEDURE ON (B)(6) 2023. ALL BROKEN FRAGMENTS WERE REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16564953 ↗
• InjuryOct 5, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A SECOND SURGERY TO REMOVE HARDWARE THAT HAD BEEN IMPLANTED (B)(6) 2018. THE SECOND SURGERY WAS TAKING PLACE DUE TO PAINFUL HARDWARE. WHEN THE SURGEON TRIED TO REMOVE THREE SCREWS FROM THE PATIENT THE HEAD BROKE OFF OF EACH OF THE SCREWS. THE BODIES OF THE SCREWS WERE LEFT IN THE PATIENT. THE HEADS THAT BROKE OFF OF THE SCREWS WERE REMOVED FROM THE PATIENT. THE SURGEON WAS USING A SCREW DRIVER BY HAND FOR THE REMOVAL. THE SCREW PART NUMBERS ARE: AR-8740-38PTS, AR-8740-40PTS, AR-8740-42PTS. THE BODY OF THE SCREWS WERE LEFT IN THE PATIENT AND ONLY THE HEADS OF THE SCREWS, WHICH BROKE OFF, WERE EXPLANTED. THE HEADS OF THE SCREWS ARE NOT AVAILABLE TO RETURN FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 10631144 ↗
• InjuryFeb 15, 2019Material Rupture

  IT WAS REPORTED ON (B)(6) 2018 THAT PATIENT WAS TREATED FOR A PATELLAR FRACTURE WITH A PATELLAR SUTURE PLATE II (AR-13070L-P) AND A COMPRESSION SCREW (AR-8740-40PTS). AFTER APPROXIMATELY 2.5 MONTHS THE PATIENT CAME BACK BECAUSE THE PATELLAR TENDON HAD RUPTURED. THE PATIENT WAS ALREADY IN REHAB AT THIS TIME AND NOTICED THE RUPTURE DURING A LUNGE. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018 DURING WHICH THE PATELLAR TENDON WAS REFIXED TRANSAXILLARY BY USING A WIRE CERCLAGE.

  Patient problems: No Information

  MAUDE report 8343701 ↗
• InjuryOct 1, 2018Break; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  DURING SOCIAL SAFEGUARD CYBER REVIEW (ARTHREX CHATTER COMMUNITY), ON 9/5/2018, A POTENTIAL DEVICE ISSUE WAS DISCOVERED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED ON 9/10/2018. ADDITIONAL INFORMATION OBTAINED 9/10/2018: DURING AN MRP FUSION PROCEDURE A 4.0 X 40MM QUICKFIX CANNULATED TITANIUM SCREW, AR-8740-40PTS (LOT UNKNOWN), BROKE AT THE END OF INSERTION. THE ONLY PART OF THE SCREW THAT BROKE WAS THE HEAD OF THE SCREW DURING THE LAST FEW TURNS OF INSERTION. THE SALES REP REPORTED, PER THE SURGEON, THAT THE SCREW IS STILL COMPRESSING THE FUSION SITE AND DOING IT'S INTENDED PURPOSE. A 3.5/4.0MM HEXALOBE T15 DRIVER (AR-8943-12) WAS BEING USED TO IMPLANT THE SCREW. IT WAS ALSO REPORTED THAT A NEW RESIDENT PHYSICIAN WAS INSERTING THE SCREW UNDER SUPERVISION OF THE ATTENDING PHYSICIAN. IT WAS REPORTED TO BE UNKNOWN IF THE SCREW BROKE DUE TO LACK OF EXPERIENCE BY THE NEW RESIDENT PHYSICIAN OR DUE TO SCREW MALFUNCTION. PRIOR TO IMPLANTATION THE BONE WAS PREPPED WITH A 2.5MM CANNULATED DRILL BIT (AR-8737-09). THE HEAD OF THE SCREW THAT BROKE OFF WAS DISCARDED BY THE FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7922141 ↗