Arthrex® AR-7229-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867041592), received between Apr 20, 2021 and Oct 25, 2023 — classified as 4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionOct 25, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING A FLEXOR TENDON SUTURE SURGERY, IT WAS FOUND THAT THE NEEDLE WAS DULL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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, KHE, 18-OCT-2023: THE FOLLOWING DEVICES WERE RECEIVED: 1 UNOPENED PACKAGE, 1 OPENED PACKAGE WITH 9 ORIGINAL PACKED NEEDLES, 2 UNPACKED NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002192 ↗
• MalfunctionFeb 27, 2023Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGERY THE NEEDLES OF THE SUTURES WERE TORN OFF TOO EASILY. THE DEVICES WERE RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444371 ↗
• MalfunctionSep 14, 2021Material Separation

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-7229-12 FIBERLOOP HAD THE NEEDLE SEPARATE FROM THE FIBERWIRE AFTER PASSING THROUGH THE TISSUE. THIS WAS DISCOVERED DURING USE IN A UCL INTERNAL BRACE PROCEDURE PERFORMED ON (B)(6) 2021. THE BROKEN PIECE OF NEEDLE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. THE REPRESENTATIVE CLAIMED THAT THIS ISSUE HAS HAPPENED MULTIPLE TIMES IN UNSPECIFIED PROCEDURES WITH THE FIBERLOOPS IN THE BATCH THEY HAVE.

  Patient problems: Insufficient Information

  MAUDE report 12467630 ↗
• MalfunctionApr 20, 2021Break; Difficult to Advance

  IT WAS REPORTED THAT DURING A DEX PROCEDURE, THE AR-7229-12, NEEDLE BROKE WHEN THE SURGEON WAS PASSING THE TENDON. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-7229-12.

  Patient problems: Insufficient Information

  MAUDE report 11692647 ↗