Arthrex® AR-1547CDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867233959), received between Jan 16, 2023 and Jul 25, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Break; Break

  ON 07/09/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT TWO AR-1547CDS BIOCOMPOSITE-TENODESIS LOOP AT THE TIP OF THE SCREWS BROKE. WHEN ATTEMPTING TO FIX THE GRAFT AND SUTURE TAPE TOGETHER TO THE TALUS, THE GRAFT DEVIATED DURING THE PROCESS, AND WHEN THE PRODUCT WAS CHECKED, THE TIP LOOP WAS BROKEN. A SECOND AR-1547CDS BIOCOMPOSITE-TENODESIS WAS OPENED AND IMPLANTED SUCCESSFULLY. HOWEVER, AFTER THE IMPLANTATION OF THE SCREW, IT WAS NOTICED THAT THE LOOP AT THE TIP OF THE INSERTER HAD BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024

  Patient problems: Insufficient Information

  MAUDE report 19828539 ↗
• MalfunctionJul 25, 2024Break; Break

  ON 07/09/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT TWO AR-1547CDS BIOCOMPOSITE-TENODESIS LOOP AT THE TIP OF THE SCREWS BROKE. WHEN ATTEMPTING TO FIX THE GRAFT AND SUTURE TAPE TOGETHER TO THE TALUS, THE GRAFT DEVIATED DURING THE PROCESS, AND WHEN THE PRODUCT WAS CHECKED, THE TIP LOOP WAS BROKEN. A SECOND AR-1547CDS BIOCOMPOSITE-TENODESIS WAS OPENED AND IMPLANTED SUCCESSFULLY. HOWEVER, AFTER THE IMPLANTATION OF THE SCREW, IT WAS NOTICED THAT THE LOOP AT THE TIP OF THE INSERTER HAD BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024

  Patient problems: Insufficient Information

  MAUDE report 19828450 ↗
• MalfunctionMay 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A TENDON REFIXATION SURGERY THE DRIVER OF THE DEVICE CUT OFF THE ASSOCIATED LOOP AT THE FRONT WITH THE METAL EDGE (FIBERWIRE LOOP). THIS HAPPENED TWICE IN ONE SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, KHE, 13-JAN-2023 5 X AR-1547CDS WERE RECEIVED (3 X USED, 2 X ORIGINAL PACKED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381087 ↗
• MalfunctionMay 2, 2024Fitting Problem; Fitting Problem

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1547CDS BIOCOMPOSITE-TENODESIS SCREW COULD NOT FIX DOWN THE GRAFT, WHICH CAUSE THE GRAFT TO FALL OUT. A NEW PRODUCT WAS USED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 7/13/2022: THIS WAS DISCOVERED DURING A RECONSTRUCTION OF ALL OF THE KNEE. THIS OCCURRED TWO CONSECUTIVELY TIMES WITH THE SAME AR-1547CDS BIOCOMPOSITE-TENODESIS SCREW. NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED USING A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19232319 ↗
• MalfunctionFeb 6, 2023Break; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ANKLE SURGERY WHEN SCREWING THE SCREW TO MAINTAIN THE LIGAMENT THE SUTURE WAS CUT THREE TIMES. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 17-JAN-2023. THIS EVENT OCCURRED DURING THE INSERTION OF THE BIOTENODESIS SCREW 4.75 INTO THE TALAR TUNNEL WITH THE TENDON GRAFT HELD AT THE END OF THE DEVICE BY THE PREASSEMBLED RETAINING WIRE. WHILE THE SURGEON INSERTED THE SCREW, THE FIBER WIRE HOLDING THE TENDON GRAFT AT THE END OF THE IMPLANT BROKE, CAUSING THE TENDON GRAFT TO PROTRUDE OUT OF THE TUNNEL. DUE TO THIS FAILURE THE SCREW HAD TO BE REMOVED IN ORDER TO CORRECTLY REINSERT THE GRAFT AT THE BOTTOM OF THE TUNNEL WITH A NEW IMPLANTING DEVICE. THE WIRE PREASSEMBLED ON THE BIO-TENODIAL SCREW WAS FOUND TO BE BROKEN ON THESE 3 PLACEMENTS, MAKING IT IMPOSSIBLE OF INTRODUCING IT AT THE BOTTOM OF THE TUNNEL. AS THE SCREW ITSELF WAS NOT DAMAGED, IT WAS NOT POSSIBLE TO ADD A GRAB WIRE TO THE DEVICE TO HOLD THE LIGAMENT GRAFT AND RETRY INSERTION OF THE GRAFT IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303053 ↗
• MalfunctionJan 16, 2023Break

  ON 12/27/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1547CDS BIOCOMPOSITE-TENODESIS SCREW BROKE A COUPLE OF THREADS DURING IMPLANTATION. THIS WAS DISCOVERED DURING AN ALLOGRAFT SYNDESMOSIS RECONSTRUCTION ON (B)(6) 2022. THE BROKEN FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW AR-1547CD. ADDITIONAL INFORMATION PROVIDED: THE PROCEDURE WAS AN ALLOGRAFT SYNDESMOSIS RECONSTRUCTION. A 5MM HOLE WAS REAMED ACROSS THE FIBULA AND TIBIA IN TWO SPOTS. THE 4.5 MM ICON GRAFT WAS SHUTTLED THROUGH BOTH TUNNELS WITH TENOSCREWS TO BE PLACED IN TIBIA TO FIXATE IT. BONE WAS RATED AS GOOD. THE FIRST 1AR-1547CDS USED WENT IN SUCCESSFULLY AND THE SECOND AR-1547CDS BROKE A COUPLE THREADS IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173286 ↗