Arthrex® AR-1915SNFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867022676), received between Aug 23, 2016 and Apr 12, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionApr 12, 2021Break

  IT WAS REPORTED THAT THE EYELETS OF TWO DEVICES FROM THE ARTICLE AR-1915SNF (LOT 11332534) TORE OFF DURING INSERTION OF THE DEVICES INTO THE BONE. NO BROKEN PARTS REMAINED INSIDE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647669 ↗
• MalfunctionApr 7, 2021Break

  IT WAS REPORTED THAT DURING A DEX PROCEDURE, THE (B)(4), ANCHOR SUTURES BROKE DURING TENSIONING. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. SURGEON USED ANOTHER OF THE SAME PRODUCT TO COMPLETE THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11631218 ↗
• InjuryOct 23, 2020Break

  IT WAS REPORTED THAT DURING A DEX PROCEDURE, THE CORKSCREW SUTURE ANCHOR, AR-1915SNF, REMAINED IN THE PATIENT'S BONE. THE SURGEON HAD TO CHANGE SURGICAL TECHNIQUE SO ANOTHER ANCHOR WAS NOT NECESSARY. NO FURTHER DETAILS, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 10/15/2020: NO INSTRUMENT WAS USED TO PREP THE PATIENT'S BONE. THE PATIENT IS SAID TO HAVE HAD GOOD QUALITY BONE. THE EYELET BROKE OFF AND WAS RETRIEVED. THE ANCHOR WAS CORRECTLY USED BUT AT SOME POINT A CLICK WAS HEARD AND THE DEVICE CAME OUT JUST WITH SUTURES. THE SURGEON CHANGED TECHNIQUE AND COMPLETED THE CASE WITH INTRAOSSEOUS TUNNELS AND SUTURES.

  Patient problems: Foreign Body In Patient

  MAUDE report 10730525 ↗
• InjuryAug 24, 2016Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD AN INTERNAL BRACE ATFL REPAIR ON (B)(6) 2016 WITH 2 LIGAMENTS REATTACHED. DURING THE REVISION THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-1678-CP (LOT 300157) ((B)(4)), AR-1915SNF (LOT 10000657 AND LOT 51277742), ((B)(4) RESPECTIVELY). PATIENT STATES HER ANKLE AND JOINT WORK GREAT AND SHE HAS HAD NO PAIN. APPROXIMATELY THE SECOND WEEK OF (B)(6) 2016 THE PATIENT BEGAN TO NOTICE RAISED, IRRITATED AND ITCHY SKIN AROUND THE INCISION. THE REACTION EXTENDS PAST THE INCISION IN A STRIP AROUND THE ANKLE BONE AS WELL AS THE CREASE AREA WHERE THE ANKLE MEETS THE FOOT. PATIENT'S SURGEON HAS DIRECTED PATIENT TO A DERMATOLOGIST. PATIENT WAS SEEN BY DERMATOLOGIST ON (B)(6) 2016. DERMATOLOGIST INFORMED PATIENT THAT THE ISSUE IS MORE LIKELY CAUSED BY SOME KELOID SCARRING AND NOT AN ALLERGIC REACTION. DERMATOLOGIST HAS INJECTED STEROID INTO SOME OF THE REACTIVE AREA. ON (B)(6) 2016 PATIENT HAD FOLLOW UP WITH THE DERMATOLOGIST. SLIGHT IMPROVEMENT WAS NOTED IN THE SMALL AREA THAT HAD RECEIVED THE STEROID INJECTION. ON (B)(6) 2016 DERMATOLOGIST INJECTED THE ENTIRE AREA. PATIENT WILL FOLLOW UP WITH DERMATOLOGIST IN APPROXIMATELY 4 WEEKS. IF THERE IS NO IMPROVE

  Patient problems: Itching Sensation; Reaction; Skin Irritation

  MAUDE report 5900595 ↗
• InjuryAug 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INTERNAL BRACE ATFL REPAIR ON (B)(6) 2016 WITH 2 LIGAMENTS REATTACHED. DURING THE REVISION THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-1678-CP (LOT 300157), AR-1915SNF (LOT 10000657 AND LOT 51277742), ((B)(4) RESPECTIVELY). PATIENT STATES HER ANKLE AND JOINT WORK GREAT AND SHE HAS HAD NO PAIN. APPROXIMATELY THE SECOND WEEK OF (B)(6) 2016 THE PATIENT BEGAN TO NOTICE RAISED, IRRITATED AND ITCHY SKIN AROUND THE INCISION. THE REACTION EXTENDS PAST THE INCISION IN A STRIP AROUND THE ANKLE BONE AS WELL AS THE CREASE AREA WHERE THE ANKLE MEETS THE FOOT. PATIENT'S SURGEON HAS DIRECTED PATIENT TO A DERMATOLOGIST. PATIENT WAS SEEN BY DERMATOLOGIST ON (B)(6) 2016. DERMATOLOGIST INFORMED PATIENT THAT THE ISSUE IS MORE LIKELY CAUSED BY SOME KELOID SCARRING AND NOT AN ALLERGIC REACTION. DERMATOLOGIST HAS INJECTED STEROID INTO SOME OF THE REACTIVE AREA. ON (B)(6) 2016 PATIENT HAD FOLLOW UP WITH THE DERMATOLOGIST. SLIGHT IMPROVEMENT WAS NOTED IN THE SMALL AREA THAT HAD RECEIVED THE STEROID INJECTION. ON (B)(6) 2016 DERMATOLOGIST INJECTED THE ENTIRE AREA. PATIENT WILL FOLLOW UP WITH DERMATOLOGIST IN APPROXIMATELY 4 WEEKS. IF THERE IS NO IMPROVEMENT DERM

  Patient problems: Itching Sensation; Scarring; Skin Irritation; Swelling

  MAUDE report 5897928 ↗