Arthrex® AR-1928SNF-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867023789), received between Mar 5, 2019 and Mar 13, 2025 — classified as 3 injuries, 4 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Positioning Failure; Positioning Failure

  ON 02/25/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1928SNF-2 SUTURE ANCHOR DOES NOT FIT SNUGLY, AND WHEN YOU TRY TO INTRODUCE IT FURTHER, THE SUTURES GRIND, LEAVING THE ANCHOR WITHOUT THEM. THIS OCCURRED DURING A LATERAL PLASTY PROCEDURE THAT WAS COMPLETED USING A NEW CORKSCREW 5.5.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21592644 ↗
• MalfunctionMay 20, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 04/26/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06550593 THAT AN AR-1928SNF-2 SUTURE ANCHOR CAME OUT ROLLED AND COULD NO LONGER BE USED. THIS OCCURRED DURING AN ACL REPAIR WHERE THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 19349956 ↗
• MalfunctionApr 25, 2024Failure to Advance; Failure to Advance

  ON 02/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1928SNF-2 CORKSCREW SUTURE ANCHOR DID NOT SEAT. THIS WAS DISCOVERED DURING A PROCEDURE ON 12/20/2021. ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 2/28/2022: EVEN THOUGH THE IMPLANT HAD NOT FULLY SEATED, SURGEON DECIDED TO LEAVE IT IN AND AND USE IT TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 3/16/2022: THIS WAS DISCOVERED DURING AN ACHILLES HAGLUND REMOVAL WITH SECONDARY ACHILLES REPAIR PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19181519 ↗
• InjuryMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT UNDERWENT A PROCEDURE WHERE AN AR-1928SNF-2- SUTURE ANCHOR WAS IMPLANTED. THE PATIENT MAY BE EXPERIENCING A REACTION. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18922954 ↗
• MalfunctionApr 18, 2022Break

  ON 03/29/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1928SNF-2 CORKSCREW ANCHOR BROKE UPON INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135448 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS PREVIOUSLY REPORTED BY A PATIENT (CASE (B)(4)) THAT THE PATIENT HAD UNDERGONE A LEFT HAMSTRING TENDON REPAIR PROCEDURE ON (B)(6) 2012. THE PATIENT HAD TORN HIS HAMSTRING OFF THE PELVIC BONE AND THE SURGEON REATTACHED IT USING TWO ARTHREX ANCHORS (AR-1928SNF-2, LOT 433344, CORKSCREW FT II SUTURE ANCHOR AND AR-18928SF-2, LOT 388268), SUTURE ANCHOR, CORKSCREW, FT II). THE PATIENT REPORTED THAT HE HAD BEEN EXPERIENCING PAIN IN PELVIC BONE AND ENTIRE LEG, TENDERNESS AND SWELLING IN ENTIRE HIP AND LEG. THE SYMPTOMS BEGAN A FEW MONTHS AFTER SURGERY WHEN IT WAS NOTICED THE PATIENT STILL HAD SWELLING WHICH HAD NOT DISSIPATED. OVER TIME DISCOMFORT STARTED WITH TINGLING IN THE LEG AND THROUGH THE YEARS THE PAIN AND SWELLING HAD INCREASED WITH CONSTANT DISCOMFORT IN THE HIP BONE. PATIENT HAD BEEN TREATED WITH PHYSICAL THERAPY AND DRUGS. AT TIME OF INITIAL REPORT PATIENT STATED HE MAY HAVE DEVELOPED AN ALLERGY TO THE METAL. MEDWATCH REPORTS (1220246-2019-00942 AND 1220246-2019-00943) WERE SUBMITTED FOR THE POSSIBLE ALLERGIC REACTION. ADDITIONAL INFORMATION OBTAINED 10/15/19: THE PATIENT HAS REPORTED THAT HE UNDERWENT A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT THE TWO ANCHORS (AR-1928SNF-

  Patient problems: Discomfort; Pain; Swelling; Tissue Damage

  MAUDE report 9289945 ↗
• InjuryMar 5, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED BY A PATIENT, VIA THE ARTHREX WEBSITE, THAT THE PATIENT HAD UNDERGONE A PROCEDURE ON (B)(6) 2012. THE PATIENT HAD TORN HIS HAMSTRING OFF THE PELVIC BONE AND THE SURGEON REATTACHED IT USING TWO ARTHREX ANCHORS, AR-1928SNF-2 (LOT 388266). PATIENT STATES HE MAY HAVE DEVELOPED AN ALLERGY TO THE METAL. PATIENT HAS REQUESTED MATERIAL COMPOSITION OF THE ANCHORS AND HAS ALSO REQUESTED THE TYPE OF HEAD THAT WOULD BE ON THE ANCHOR AND WHAT INSTRUMENT HIS CURRENT ORTHOPEDIC SURGEON WILL NEED TO REMOVE THE ANCHORS. THE REQUESTED INFORMATION WILL BE PROVIDED TO THE PATIENT. THE PART AND LOT NUMBER PROVIDED BY THE PATIENT ARE NOT A VALID MATCH. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PATIENT. ADDITIONAL INFORMATION OBTAINED 2/15/19: PER THE SURGERY IMPLANT LOG, THE TWO DEVICES IMPLANTED DURING THE (B)(6) 2012 PROCEDURE WERE: AR-1928SNF-2, LOT 433344, CORKSCREW FT II SUTURE ANCHOR. AR-18928SF-2, LOT 388268, SUTURE ANCHOR, CORKSCREW, FT II 5.5MM. THE (B)(6) 2012 PROCEDURE WAS A LEFT HAMSTRING TENDON REPAIR. THE PATIENT'S SYMPTOMS INCLUDE PAIN IN PELVIC BONE AND ENTIRE LEG, TENDERNESS AND SWELLING IN ENTIRE HIP AND LEG. THE SYMPTOMS BEGAN A FEW MONTHS AFTER SURGERY WHEN I

  Patient problems: Discomfort; Pain; Reaction; Swelling; Tingling

  MAUDE report 8390816 ↗