Arthrex® AR-1322-752SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867010130), received between Mar 16, 2017 and Feb 11, 2026 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Failure to Advance

  ON (B)(6) 2026, A COMPETENT AUTHORITY REPORTED VIA EMAIL THAT AN AR-1322-752SF SMALL BONE FASTAK SUTURE ANCHOR WAS DEPLOYED BUT DID NOT REMAIN DOCKED IN THE BONE. THE ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 23-JAN-2026: THIS WAS DISCOVERED DURING A UCL THUMB PROCEDURE. THERE WERE TWO AR-1322-752SF SMALL BONE FASTAK SUTURE ANCHOR THAT WERE REMOVED FROM THE PATIENT AS THE ANCHORS PULLED OUT OF THE BONE. A REPLACEMENT AR-1322-752SF SMALL BONE FASTAK SUTURE ANCHOR WAS USED TO COMPLETE THE CASE. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312560 ↗
• MalfunctionFeb 9, 2026Failure to Advance

  ON 19-JAN-2026, A COMPETENT AUTHORITY REPORTED VIA EMAIL THAT AN AR-1322-752SF SMALL BONE FASTAK SUTURE ANCHOR WAS DEPLOYED BUT DID NOT REMAIN DOCKED IN THE BONE. THE ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 23-JAN-2026: THIS WAS DISCOVERED DURING A UCL THUMB PROCEDURE. THERE WERE TWO AR-1322-752SF SMALL BONE FASTAK SUTURE ANCHOR THAT WERE REMOVED FROM THE PATIENT AS THE ANCHORS PULLED OUT OF THE BONE. A REPLACEMENT AR-1322-752SF SMALL BONE FASTAK SUTURE ANCHOR WAS USED TO COMPLETE THE CASE. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299034 ↗
• MalfunctionMar 17, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(6) THAT (2) AR-1322-752SF SMALL BONE FASTAK¿ SUTURE ANCHOR WITH 2-0 FIBERWIRE DID NOT RELEASE CORRECTLY. THIS OCCURRED DURING REPAIR OF ULNAR COLLATERAL LIGAMENT WHEN THE FIRST ANCHOR DID NOT RELEASE CORRECTLY. IT EMBEDDED PARTIALLY. THE SURGEON HAD TO FINISH ANCHORING IT IN USING A MALLET. THIS DID NOT WORK AND SHE THEN HAD TO CUT IT OUT AND TRY AGAIN AT A DIFFRENT SITE. A NEW SUTURE ANCHOR WAS OPENED AND THIS ONE ALSO DID NOT DEPLOY CORRECTLY. IT CUT BOTH THE SUTURES WHEN SHE WENT TO RELEASE IT.

  Patient problems: Insufficient Information

  MAUDE report 21619664 ↗
• MalfunctionMar 17, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) AR-1322-752SF SMALL BONE FASTAK¿ SUTURE ANCHOR WITH 2-0 FIBERWIRE DID NOT RELEASE CORRECTLY. THIS OCCURRED DURING REPAIR OF ULNAR COLLATERAL LIGAMENT WHEN THE FIRST ANCHOR DID NOT RELEASE CORRECTLY. IT EMBEDDED PARTIALLY. THE SURGEON HAD TO FINISH ANCHORING IT IN USING A MALLET. THIS DID NOT WORK AND SHE THEN HAD TO CUT IT OUT AND TRY AGAIN AT A DIFFERENT SITE. A NEW SUTURE ANCHOR WAS OPENED AND THIS ONE ALSO DID NOT DEPLOY CORRECTLY. IT CUT BOTH THE SUTURES WHEN SHE WENT TO RELEASE IT.

  Patient problems: Insufficient Information

  MAUDE report 21619577 ↗
• InjuryNov 21, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A WRIST LIGAMENT REATTACHMENT PROCEDURE, THE SURGEON SCREWED IN THE FASTTAK, UNSLID THE DOOR, PULLED OUT THE HANDLE AND BEGAN TO ATTACH THE TENDON WHEN THE FIBERWIRE SNAPPED-OFF FROM THE BASE OF THE ANCHOR LEAVING TWO TAILS WITH NEEDLES ON EACH. THE ANCHOR WAS REMOVED AND THE SURGEON DRILLED TUNNELS AND PASSED SUTURE TO TIE THE TENDON DOWN INSTEAD. THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. FOLLOW-UP INVESTIGATION: ALL COMPONENTS WERE RETRIEVED FROM THE PATIENT. THE INSERTER WITH METAL ANCHOR AND SUTURE ARE BEING SENT BACK TO ARTHREX FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7048069 ↗
• InjuryMar 16, 2017Break

  IT WAS REPORTED THAT DURING AN ATFL REPAIR PROCEDURE, THE DRIVER SHAFT ON THE SMALL BONE FASTAK¿ SUTURE ANCHOR WITH 2-0 FIBERWIRE BROKE AS THE ANCHOR WAS BEING SEATED INTO THE BONE. ALL METAL FRAGMENTS WERE REMOVED FROM THE PATIENT AND THE TIP OF THE DRIVER WAS REMOVED FROM THE ANCHOR, HOWEVER, THE BROKEN ANCHOR HAD TO BE LEFT IN. THE SURGEON WAS ABLE TO TRIM THE ANCHOR DOWN TO BE FLUSH WITH THE BONE. A NEW SMALL BONE FASTAK¿ SUTURE ANCHOR WITH 2-0 FIBERWIRE WAS USED IN AN ADJACENT SPOT TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6411487 ↗