Arthrex® AR-1896Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867022423), received between Sep 12, 2016 and Jul 26, 2024 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1896 SCRWDRV,CANN.,PINLOCK II,3.5MM HEX SNAPPED DURING USE. THIS OCCURRED ON (B)(6) 2024 IN (B)(6) HOSPITAL DURING AN ACL REVISION. IT WAS REPORTED THAT A METAL INTERFERENCE SCREW WAS BEING INSERTED INTO A FEMORAL TUNNEL. THE FEMORAL TUNNEL DIAMETER WAS 10MM, BTB GRAFT WAS 10MM AND THE SURGEON SELECTED A 9MM SCREW. ON INSERTION THE SURGEON NOTED THE "TOUGH" INSERTION AND WITH ROUGHLY 2 TURNS TO GO THE SCREW INSERTER SNAPPED AT THE HEX DRIVER POINT (PICTURED). THE BROKEN FRAGMENT WAS LEFT IN THE INSERTION POINT OF THE SCREW. THE NITIOL WIRE WAS LEFT IN PLACE, SO THAT THE FRAGMENT WAS NOT LOST IN THE JOINT SPACE AND A GRASPER WAS USED TO REMOVE THE FRAGMENT. THE CASE WAS COMPLETED SUCCESSFULLY USING AN 8MM PEEK INTERFERENCE SCREW WHICH HAD BEEN TAPPED BY THE METAL SCREW. THERE WAS CASE INVOLVEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19839481 ↗
• MalfunctionMay 10, 2021Break

  IT WAS REPORTED, THAT DURING AN ACL REVISION PROCEDURE, WHEN THE SURGEON WAS REMOVING THE SCREW THE TIP OF THE AR-1896, BROKE. IT IS UNKNOWN AT THIS TIME IF THE SCREW REMOVED IS AN ARTHREX DEVICE. ALL PIECES WERE REMOVED. THE CASE WAS COMPETED USING A COMPETITOR DEVICE. THE AR-1896 WILL BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 11802291 ↗
• InjuryDec 16, 2019Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN ACL PROCEDURE THE TIP OF THE DRIVER BROKE OFF IN THE PATIENT. THE DRIVER TIP WAS STUCK IN THE SCREW AND COULD NOT BE RETRIEVED. REPORTER STATED THE SCREW WAS SEATED AND ALL IS SECURE. PER REPORTER, THE PATIENT IS FINE TO DATE AND THE DOCTOR FEELS THERE IS NO NEED FOR A REVISION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9473440 ↗
• InjurySep 12, 2016Break

  IT WAS REPORTED VIA A FACILITY MEDWATCH ((B)(4)) THAT ON (B)(6) 2016 DURING AN ACL RECONSTRUCTION PROCEDURE, THE SURGEON WAS USING THE AR-1896 SCREWDRIVER TO PLACE A SCREW AND THE TIP OF THE SCREWDRIVER BROKE-OFF IN THE HEAD OF THE SCREW. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE REPORTER OF MEDWATCH (B)(4). TO DATE NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Information

  MAUDE report 5943432 ↗