Arthrex® AR-1320BCNFRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867009813), received between Aug 31, 2016 and Jun 2, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Break; Break

  ON 15TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1320BCNF, SUTURE ANCHOR, MICRO BIOCOMPOSITE SUTURETAK® 2.4 X 6.5 MM WITH 2-0 FIBER WIRE® WITH TWO TAPER POINT NEEDLES, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A REPAIR SURGERY FOR ANTERIOR TALOFIBULAR LIGAMENT INJURY OF THE ANKLE JOINT SURGERY ON (B)(6) 2025. THE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1320BCNF. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURES NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123281 ↗
• MalfunctionMar 20, 2025Break; Break

  ON 10TH MARCH 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1320BCNF, SUTURE ANCHOR, MICRO BIOCOMPOSITE SUTURETAK® 2.4 X 6.5 MM WITH 2-0 FIBER WIRE® WITH TWO TAPER POINT NEEDLES'S ANCHOR BROKE OFF DURING INSERTION. THIS WAS DISCOVERED DURING A REPAIRING OF ANTERIOR TALOFIBULAR LIGAMENT INJURY OF ANKLE JOINT SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1320BCNF. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURES NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650858 ↗
• MalfunctionSep 16, 2024Break; Break

  ON 2ND SEPTEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1320BCNF, SUTURE ANCHOR, MICRO BIOCOMPOSITE SUTURETAK® 2.4 X 6.5 MM WITH 2-0 FIBER WIRE® WITH TWO TAPER POINT NEEDLES, THE ANCHOR WAS BROKEN DURING INSERTION. THIS WAS DETECTED DURING REPAIR OF ANTERIOR TALOFIBULAR LIGAMENT INJURY OF ANKLE JOINT SURGERY ON (B)(6) 2024. A 2.0MM DRILL HEAD FROM AR-1320DSC KIT WAS USED TO PREPARE BONE SOCKET. THE END OF THE ANCHOR BROKE DURING INSERTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM BY USING ANOTHER NEW AR-1320BCNF INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225782 ↗
• MalfunctionJun 3, 2024Break; Break

  ON 9TH MAY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1320BCNF, SUTURE ANCHOR, MICRO BIOCOMPOSITE SUTURETAK® 2.4 X 6.5 MM WITH 2-0 FIBER WIRE® WITH TWO TAPER POINT NEEDLES, THE ANCHOR WAS BROKEN DURING INSERTION. THIS WAS DETECTED DURING USE IN AN ANKLE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER BRAND'S PRODUCT WAS USED. . PIECES BROKE INSIDE THE PATIENT BUT ALL FRAGMENTS WERE RETRIEVED. NO PATIENT HARM AND NO SECONDARY PROCEDURE WERE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454083 ↗
• MalfunctionFeb 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 2/13/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-1320BCNF SUTURE ANCHOR PULLED OUT. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18810053 ↗
• MalfunctionDec 13, 2021Break; Physical Resistance/Sticking

  ON 11/23/2021 , IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR1320BCNF SUTURETAK ANCHOR WAS IMPLANTED AND THE INSERTER SHAFT GOT STUCK TO THE IMPLANT. THIS WAS DISCOVERED DURING ANKLE LIGAMENT REPAIR AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2021. BECAUSE THE SHAFT COULD NOT BE TAKEN OUT, THE IMPLANT BROKE. SURGEON COMPLETED PROCEDURE BY OPENING A NEW AR-1320BCNF SUTURETAK FROM A DIFFERENT LOT NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 12984975 ↗
• InjuryMay 2, 2019Improper or Incorrect Procedure or Method; Expiration Date Error

  IT WAS REPORTED THAT AN EXPIRED AR-1320BCNF, SUTURE ANCHOR MICRO BIOCOMPOSITE SUTURETAK (LOT: 10128646) WAS IMPLANTED DURING AN INTER-POSITIONAL ARTHROPLASTY OF THE SECOND METATARSAL PROCEDURE. THE REP STATED THE DEVICE WAS FACILITY OWNED AND WAS TAKEN FROM THE FACILITY'S STOCK. THE DEVICE EXPIRED ON 02/28/2019. THE CIRCULATOR NOTICED THE EXPIRATION DATE LABELED ON THE IMPLANT STICKER AFTER THE SURGEON HAD ALREADY IMPLANTED THE DEVICE. THE SURGEON ATTEMPTED TO REMOVE THE IMPLANT, BUT WAS ONLY ABLE TO REMOVE THE SUTURE. THE REP CONFIRMED THE ANCHOR BODY REMAINS IMPLANTED. IN THE ATTEMPTS MADE TO REMOVE THE ANCHOR BODY, THE SURGEON REMOVED MORE BONE THAN THEY ORIGINALLY PLANNED FOR THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574246 ↗
• InjuryAug 31, 2016Loose or Intermittent Connection; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A HAND TFCC RECONSTRUCTION PROCEDURE THE DISPOSABLE KIT AR-1320DSC LOT 1188386 ((B)(4)) DID NOT HAVE THE NECESSARY DRILL SLEEVE. THE SURGEON DRILLED FOR THE ANCHORS WITHOUT USING A DRILL SLEEVE. AS A RESULT THE ANCHORS AR-1320BCNF, LOT 1304766 (QTY 2) ((B)(4)) WERE NOT SECURE AND PULLED OUT. THE PROCEDURE WAS NOT COMPLETED AS PLANNED. INSTEAD THE PROCEDURE WAS COMPLETED BY CHANGING THE TECHNIQUE AND USING BONE TUNNELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5918103 ↗