Arthrex® AR-1319FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867008533), received between Sep 10, 2018 and Jun 3, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE ANCHOR ON THE AR-1319FT WAS NOT ATTACHED, WHEN THE NEW PRODUCT WAS OPENED. USED A NEW PRODUCT AND THE CASE IS COMPLETED. NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19449136 ↗
• MalfunctionMay 23, 2024Component Missing; Component Missing

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1319FT MINI CORKSCREW DID NOT HAVE AN ANCHOR. THIS WAS DISCOVERED UPON OPENING PACKAGE FOR A PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED USING ANOTHER PRODUCT. ADDITIONAL INFORMATION RECEIVED 1/26/2022: THIS WAS DISCOVERED UPON OPENING PACKAGE FOR A DETACHMENT FRACTURE OF THE ELBOW PROCEDURE. SURGEON COMPLETED CASE USING ANOTHER AR-1319FT FROM AN UNKNOWN LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381565 ↗
• MalfunctionApr 29, 2024Defective Device; Defective Device

  ON 7/21/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1319FT MINI CORKSCREW ANCHOR HAD COME OFF AND COULD NOT BE USED. ANOTHER ONE WAS OPENED, FROM THE SAME LOT NUMBER, AND THE SAME THING HAPPENED. THIS WAS DISCOVERED UPON OPENING PACKAGE DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 7/22/2022: THIS WAS DISCOVERED DURING A PRE-OPERATIVE CHECK SO NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203556 ↗
• MalfunctionApr 26, 2021Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A LIGAMENT FOOT SURGERY THE ANCHOR AR-1319FT REMAINED INSIDE THE PATIENT. THE SURGEON REPORTED THAT 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 12-APR-2021: FURTHER INFORMATION WERE PROVIDED THAT THE DEVICE BROKE OFF INSIDE PIECE WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11725150 ↗
• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIAL COLLATERAL LIGAMENT REPAIR ON HER RIGHT THUMB ON (B)(6) 2017 WHERE AN ARTHREX TITANIUM ANCHOR (PART NUMBER UNKNOWN) WAS IMPLANTED. SHE REPORTED THAT SHE IS NOW EXPERIENCING PERSISTENT PAIN AND SWELLING IN THE JOINT, EVEN AT REST. THE PATIENT WILL BE SEEING AN ALLERGIST TO SEE IF SHE HAS AN ALLERGY TO TITANIUM. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION OBTAINED 8/24/2018: PATIENT HAS PROVIDED THE PART NUMBER OF THE ANCHOR. IT WAS AN AR-1319FT, SUTURE ANCHOR, MINI CORKSCREW FT. THE LOT NUMBER PROVIDED BY THE PATIENT (LOT 10133878) IS NOT A VALID LOT NUMBER FOR THIS DEVICE.

  Patient problems: Joint Swelling; Pain

  MAUDE report 7860866 ↗