Arthrex® AR-1540PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867018747), received between Jan 2, 2019 and Mar 10, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 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 10, 2025Break; Break

  ON 02/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1549PS TENODESIS SCREW, PEEK, VENTED, 4 X 10 MM BROKE IN HALF UPON INSERTION TO THE BONE TUNNEL. THE PIECES WERE EXTRACTED AND AN ADDITIONAL AR-1549PS TENODESIS SCREW WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02/25/2025: THERE WAS NO CASE DELAY, AND NO ADDED ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED DURING OR AFTER THE SURGERY. THIS WAS DISCOVERED DURING A SCAPHOLUNATE STABILIZATION PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558812 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SCAPHOLUNATE DISSECTION REPAIR, THE SURGEON FIXED THE GRAFT TENDON AND THE TAPE ON THE BONE WITH A PEEK TENODESIS SCREW, AR-1540PS. WHEN HE TRIED TO REMOVE THE DRIVER, THE REMOVAL WAS DIFFICULT. THE SURGEON HAD TO PULL IT OUT WITH PLIERS AND A HAMMER. AT THIS TIME, THE BONES AROUND THE FIXATION SITE WERE BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER MANUFACTURER'S DEVICES. NO FURTHER INFORMATION PROVIDED. FURTHER INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 5/21/2019: THE BONE FRACTURED WHEN THE SCREW WAS PULLED FROM THE BONE. NO PART OF THE SCREW OF THE DRIVER BROKE. THE SURGEON ORIGINALLY PLANNED TO REPAIR THE SCAPHOLUNATE WITH ONLY THREE ANCHORS BUT BECAUSE THE BONE WAS FRACTURED, HE HAD TO USE MANY MORE ANCHOR FROM ANOTHER MANUFACTURER TO SEW THE TISSUE AND BONE TOGETHER. THE FRACTURE LED THE PATIENT TO A CAST FOR 8 WEEKS POST-OP. THERE WERE NO X-RAYS TAKEN. ADDITIONAL INFORMATION PROVIDED 10/2/2019: THE GRAFT DIAMETER WAS 2-3MM AFTER WHIPSTITCHING. THE DRILL FOR THE DX SWIVELOCK 3.5MM*8.5MM WAS USED. THE SURGEON DID NOT TRY TO BACK THE SCREW OUT, HE TRIED TO PULL OUT THE DRIVER.

  Patient problems: Bone Fracture(s)

  MAUDE report 8699376 ↗
• InjuryJan 2, 2019Difficult to Insert

  IT WAS REPORTED THAT DURING A MCL RECONSTRUCTION, THE SURGEON TRIED TO INSERT THE PEEK TENODESIS SCREW, AR-1540PS, BUT COULD NOT GET IT TO ENGAGE. A SECOND PEEK TENODESIS SCREW, AR-1540PS WAS OPENED AND INSERTED ON THE ULNAR SIDE. NO FURTHER DETAILS, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 12/28/2018: IT WAS REPORTED THAT SINCE THE SURGERY WAS OPEN PROCEDURE, THE SURGEON DID NOT HAVE TO CREATE A PORTAL ON THE ULNAR SIDE. WHEN ASKED THE QUALITY OF BONE, THE RESPONSE WAS "NOT PROVIDED." NO FURTHER DETAILS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8209219 ↗
• InjuryJan 2, 2019Difficult to Insert

  IT WAS REPORTED THAT DURING A MCL RECONSTRUCTION, THE SURGEON TRIED TO INSERT THE PEEK TENODESIS SCREW, AR-1540PS, BUT COULD NOT GET IT TO ENGAGE. A SECOND PEEK TENODESIS SCREW, AR-1540PS WAS OPENED AND INSERTED ON THE ULNAR SIDE. NO FURTHER DETAILS, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 12/28/2018: IT WAS REPORTED THAT SINCE THE SURGERY WAS AN OPEN PROCEDURE, THE SURGEON DID NOT HAVE TO CREATE A PORTAL ON THE ULNAR SIDE. WHEN ASKED THE QUALITY OF BONE, THE RESPONSE WAS "NOT PROVIDED." NO FURTHER DETAILS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8209169 ↗