Arthrex® AR-1318FT-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867008526), received between Jan 12, 2018 and Feb 18, 2025 — classified as 2 injuries, 7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 1/29/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1318FT-40 CORKSCREW FT ANCHORS HAD ISSUES. THE FIRST CORKSCREW FT TIP BENT DURING INSERTION AND CUT THE SUTURE THROUGH THE FIBERWIRE, RENDERING THE ANCHOR USELESS. THE SECOND CORKSCREW WAS OPENED BUT THE DRIVER WOULD NOT BACK OUT OF THE SCREW. THE CASE WAS COMPLETED USING A NANO CORKSCREW IN THE DISTAL LOCATION. THIS WAS DISCOVERED DURING AN INDEX FINGER RADIAL COLLATERAL LIGAMENT REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 2/5/2025: EVERYTHING WAS REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED USING AN AR-1317FT NANO CORKSCREW FT. THE CASE WAS DELAYED FIFTEEN MINUTES AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 21392900 ↗
• MalfunctionJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AT THE TIME OF OPENING, THE ANCHOR HAD FALLEN OFF. NO ADVERSE EFFECT ON THE PATIENT. USED A NEW PRODUCT AND THE CASE IS COMPLETED. NO PATIENT HARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477197 ↗
• MalfunctionJun 4, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING SCAPHOLUNATE LIGAMENT RECONSTRUCTION SURGERY WHILE UNPACKING IT WAS NOTICED, THAT THE ANCHOR IS MISSING AND THE SUTURES WERE NOT CLAMPED INTO THE ANCHOR. THERE WAS NO HARM OR ADVERSE EVENT 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463721 ↗
• MalfunctionMay 8, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 10/8/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-1317FT NANO CORKSCREW AND (2) AR-1318FT-40 MICRO SUTURE ANCHOR CORKSCREW TIPS BENT WHILE INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021, WHEN SURGEON MADE A PILOT HOLE, AR-1317FT TIP BENT AND THE BONE QUALITY WAS HARD. THIS WAS ATTEMPTED AGAIN WITH ANOTHER NANO CORKSCREW AND THE DRIVER TIP BENT WHEN IT WAS ABOUT 80% INSERTED. THE SAME HAPPENED WHEN AR-1318FT-40 SCREW WAS INSERTED. FINALLY, SURGEON WAS ABLE TO INSERT AND SUTURE ONE NANO AND ONE MICRO CORKSCREW TO COMPLETE CASE. ADDITIONAL INFORMATION RECEIVED 10/11/2021 SURGEON TRIED TO USE ANOTHER AR-1318FT-40 A SECOND TIME AND TIP WAS ALSO BENT. THERE WERE NO BROKEN PIECES INSIDE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19265955 ↗
• InjurySep 14, 2021Collapse; Positioning Problem

  ON  (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA TELEPHONE THAT AN AR-1318FT-40 MICRO CORKSCREW SUTURE ANCHOR WOULD NOT SEAT, THE ANCHOR WAS COLLAPSING. THE SURGEON TRIED TWICE USING THE AR-1318FT-40. THIS WAS DISCOVERED DURING AND HAND AND WRIST UCL PROCEDURE. THE CASE WAS COMPLETED BY REPAIRING THE ULNAR COLLATERAL LIGAMENT USING 2.0 FIBERWIRE.

  Patient problems: Insufficient Information

  MAUDE report 12466736 ↗
• MalfunctionAug 24, 2021Break; Disconnection

  IT WAS REPORTED THAT DURING A HAND LIGAMENT REPAIR, THE FIRST SCREW WAS DISCONNECTED FROM THE SCREWDRIVER AND COULD NOT BE USED. AFTER INSERTING THE SECOND SCREW INTO THE BONE HOLE, THE SUTURE BROKE WHEN THE SUTURE WAS LIGATED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 08/11/2021: THE SCREW AND THE SUTURE ARE PULLED TOGETHER AND BROKE FROM THE JOINT. ALL FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED BY CREATING A BONE TUNNEL THAT PENETRATES THE FIXATION PART AND FIX IT WITH NYLON THREAD.

  Patient problems: Insufficient Information

  MAUDE report 12362374 ↗
• MalfunctionAug 3, 2021Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE TIPS OF THE HANDLES OF THREE DEVICES AR-1318FT-40 (LOT 11838516) TORQUED OR BROKE OFF. THE BREAKAGE OCCURRED OUTSIDE OF THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 16-JUL-2021: IT WAS CONFIRMED THAT THE DEVICES BROKE DURING IMPLANTATION INSIDE THE PATIENT. THE DEVICES WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268381 ↗
• MalfunctionMar 31, 2021Break

  IT WAS REPORTED THAT THE ANCHOR WAS DETACHED FROM THE TIP OF THE MICRO CORKSCREW SUTURE ANCHOR, AR-1318FT-40. THERE SURGEON WAS ABLE TO REATTACH IT; HOWEVER, THE SUTURE BROKE DURING INSERTION. A NEW MICRO CORKSCREW SUTURE ANCHOR WAS OPENED TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599106 ↗
• InjuryJan 12, 2018Bent; Break; Material Frayed

  IT WAS ORIGINALLY REPORTED THAT THE SUTURE ANCHOR DRIVER BROKE OFF AND/OR BENT, IMPACTING ON THE SUTURE AND CAUSING IT TO FRAY. TWO OF THE ANCHORS COULD NOT BE RETRIEVED AND WERE LEFT IN THE PATIENT. TWO DIFFERENT LOTS WERE USED SUCCESSFULLY. PATIENT: (B)(6) MALE; (B)(6). CASE: DISTAL RADIUS. FOLLOW-UP INVESTIGATION: THREE UNITS OF THE SAME LOT DID NOT WORK AS INTENDED. NONE OF THE ANCHORS THEMSELVES BROKE. TWO OF THE ANCHORS HAD THE DRIVER BREAK-OFF IN THE ANCHOR AND ONE OF THE DRIVERS CRIMPED SHUT, CAUSING THE SUTURE TO FRAY. ONE ANCHOR WAS SUCCESSFULLY RETRIEVED. TWO (2) ANCHORS WERE LEFT IN BONE, SITTING FLUSH WITH A PIECE OF THE DRIVER INSIDE THE ANCHOR. ALL SUTURE WAS RETRIEVED. THE THREE DRIVERS IN QUESTION ARE BEING RETURNED FOR EVALUATION. TO COMPLETE THE PROCEDURE TWO ANCHORS/DRIVERS FROM A DIFFERENT LOT WERE USED WITHOUT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7185387 ↗