Arthrex ABS-2014-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889981153694), received between Jul 29, 2021 and May 21, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE PATIENT WAS 3 WEEKS OUT FROM ACL TUNNEL BONE GRAFTING WITH DOWELS PROCEDURE WHICH OCCURRED ON (B)(6) 2021. THAT WAS THE FIRST STAGE OF A REVISION FROM AN ACL PROCEDURE FROM YEARS AGO. DURING THE FIRST FOLLOW UP A WEEK POST OP ON (B)(6) 2021 THE PATIENT HAD MILD PAIN AND MODERATE SWELLING. ON (B)(6) THE PATIENT WENT TO THE EMERGENCY DEPARTMENT REPORTING THE SWELLING AND PAIN HAS INCREASED. ON (B)(6) 2021 HE CAME IN TO SEE THE DOCTOR AND THE EXAM REPORTED ACTIVE DRAINAGE OVER THE INCISION AND WAS DIAGNOSED WITH AN INFECTION. IT WAS DETERMINED ALL OF THE IMPLANTED ITEMS WILL NEED TO BE REMOVED INCLUDING THE ALLOSYNC PUTTY AND TWO DOWELS. ADDITIONAL INFORMATION: THE DOWELS (NOT AN ARTHREX ITEM) WERE REAMED OUT ALONG WITH THE PUTTY. THE ONLY ARTHREX PRODUCT REMOVED DURING THIS PROCEDURE WAS THE ABS-2014-10.

  Patient problems: Unspecified Infection

  MAUDE report 19357818 ↗
• InjuryJan 5, 2024Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  ON (B)(6) 2021, AN ACL TUNNEL BONE GRAFT WITH DOWELS PROCEDURE WAS PERFORMED. THE PROCEDURE WAS THE 1ST STAGE REVISION OF A SURGERY THAT OCCURRED SEVERAL YEARS PRIOR. ON (B)(6) 2021 AT A FOLLOW UP, THE PATIENT COMPLAINED OF MILD PAIN AND MODERATE SWELLING. ON (B)(6) 2021, THE PATIENT WAS SEEN IN AN EMERGENCY ROOM REPORTING INCREASED SWELLING AND PAIN. ON (B)(6) 2021, THE PATIENT FOLLOWED UP WITH THEIR PROVIDER AND WAS DIAGNOSED WITH AN INFECTION. IT WAS DETERMINED THAT ALL THE ITEMS IMPLANTED WOULD NEED TO BE REMOVED, INCLUDING THE ABS-2014-10 ALLOSYNC CB DBM PUTTY, 10CC AND 2 DOWELS. THE DOWELS ARE NOT ARTHREX ITEMS. THE EVENTS DESCRIBED ABOVE WERE PREVIOUSLY INACCURATELY REPORTED THROUGH REPORT NUMBER 3012120772-2021-00068. THIS REPORT IS ISSUED TO RECTIFY THIS MISTAKE AND SUBSTITUTE THE PRIOR REPORT FILED UNDER THE INCORRECT REGISTRY.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 18455850 ↗
• MalfunctionJul 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, AN ACL TUNNEL BONE GRAFT WITH DOWELS PROCEDURE WAS PERFORMED. THE PROCEDURE WAS THE 1ST STAGE REVISION OF A SURGERY THAT OCCURRED SEVERAL YEARS PRIOR. ON (B)(6) 2021 AT A FOLLOW UP, THE PATIENT COMPLAINED OF MILD PAIN AND MODERATE SWELLING. ON (B)(6) 2021, THE PATIENT WAS SEEN IN AN EMERGENCY ROOM REPORTING INCREASED SWELLING AND PAIN. ON (B)(6) 2021, THE PATIENT FOLLOWED UP WITH THEIR PROVIDER AND WAS DIAGNOSED WITH AN INFECTION. IT WAS DETERMINED THAT ALL THE ITEMS IMPLANTED WOULD NEED TO BE REMOVED, INCLUDING THE ABS-2014-10 ALLOSYNC CB DBM PUTTY, 10CC AND 2 DOWELS. THE DOWELS ARE NOT ARTHREX ITEMS.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 12250400 ↗