Arthrex® AR-1547BC-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867315150), received between May 12, 2025 and Aug 5, 2025 — classified as 2 malfunctions.

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

• MalfunctionAug 5, 2025Break; Failure to Advance; Break; Failure to Advance

  ON 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT DURING AN FHL TRANSFER PROCEDURE PERFORMED ON (B)(6) 2025, AN AR-1547BC-CP FDL IMPLANT SYSTEM EXPERIENCED A MALFUNCTION. SPECIFICALLY, THE 4.75 MM TENODESIS SCREW BROKE IN HALF AT ITS TOP WHILE BEING INSERTED HALFWAY. ALL BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT. TO COMPLETE THE PROCEDURE, THEY UTILIZED THE 5 MM REAMER INCLUDED IN THE KIT TO REAM OVER THE SITE AND SUCCESSFULLY IMPLANTED A 6.25 MM TENODESIS SCREW WITHOUT FURTHER ISSUES. THE CASE WAS DELAYED BY 15 MINUTES, WITH NO ADDITIONAL ANESTHESIA REQUIRED. NO ADVERSE EFFECTS WERE REPORTED DURING OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720614 ↗
• MalfunctionMay 12, 2025Break; Break

  A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1547BC-CP FDL IMPLANT SYSTEM HAD AN ISSUE DURING A FDL TRANSFER PROCEDURE. WHEN THE SURGEON WENT TO PUT IN THE SCREW AND TURNED IT CLOCKWISE, THE SCREW WAS DELAMINATING AND DISINTEGRATING UPON INSERTION, AND BROKE. THERE WAS BIOCOMPOSITE DEBRIS PRODUCED INSIDE THE PATIENT, THE BROKEN SCREW AND ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ANOTHER AR-1547BC-CP FDL IMPLANT SYSTEM WITH A DIFFERENT LOT NUMBER, 15332204, WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY; THERE WAS NO HARM TO THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED, BUT A PICTURE WAS TAKEN. THERE WAS A 2-MINUTE CASE DELAY, AND IT COULD NOT BE CONFIRMED IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004324 ↗