Arthrex® AR-1915SNF-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867022683), received between Jan 5, 2021 and Nov 22, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2022Break

  IT WAS REPORTED THAT DURING AN ACHILLES TENDON REFIXATION SURGERY THE ANCHOR BROKE OFF WHILE SCREWING IN. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE TREATMENT WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM A DIFFERENT MANUFACTURER. IT WAS NOT NECESSARY TO DO A SECOND TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842695 ↗
• MalfunctionMar 5, 2021Break

  IT WAS REPORTED THAT DURING ACHILLES TENDON REFIXATION THE ANCHOR BROKE OFF WHILE INSERTING. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11420772 ↗
• MalfunctionJan 5, 2021Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A REINSERTION OF THE PECTORALIS MAJOR TENDON SURGERY THE THREADS OF AR-1915SNF-1 BROKE DURING SUTURING. SURGEON WANTED TO USE CORKSCREW 3.5MM OPEN NEEDLE ANCHORS. ONE OF THE THREE ANCHORS OF THIS SIZE PLACED BROKE DURING INSERTION BETWEEN THE BODY OF THE SCREW AND THE EYELET FOR PASSING THE THREADS. WITH ONE OTHER THE TWO THREADS BROKE WHEN TIGHTENING THE KNOTS. THEN THE SURGEON TOOK THE CORKSCREW 5.5 WITH REINFORCED THREADS BUT AT THE FIRST, THE SUPPORT SCREWDRIVER BROKE BEFORE THE SCREW WAS COMPLETELY INSERTED. SURGEON TRIED TO SCREW IT IN DESPITE OF EVERYTHING BUT WITHOUT SUCCESS AND THE TWO THREADS WERE VERY DAMAGED. ONLY THE METAL CORE REMAINED. SURGEON FINISHED THE SURGERY WITH REMOVING IT TO DRILL AT 4.5MM BEFORE INSERTING A NEW SCREWED ANCHOR. IN THE END, THERE ARE FOUR ANCHORS IN THE PATIENT´S HUMERUS, TWO OF THEM ARE UNNECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11119637 ↗
• InjuryJan 5, 2021Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A REINSERTION OF THE PECTORALIS MAJOR TENDON SURGERY THE THREADS OF AR-1915SNF-1 BROKE DURING SUTURING. SURGEON WANTED TO USE CORKSCREW 3.5MM OPEN NEEDLE ANCHORS. ONE OF THE THREE ANCHORS OF THIS SIZE PLACED BROKE DURING INSERTION BETWEEN THE BODY OF THE SCREW AND THE EYELET FOR PASSING THE THREADS. WITH ONE OTHER THE TWO THREADS BROKE WHEN TIGHTENING THE KNOTS. THEN THE SURGEON TOOK THE CORKSCREW 5.5 WITH REINFORCED THREADS BUT AT THE FIRST, THE SUPPORT SCREWDRIVER BROKE BEFORE THE SCREW WAS COMPLETELY INSERTED. SURGEON TRIED TO SCREW IT IN DESPITE OF EVERYTHING BUT WITHOUT SUCCESS AND THE TWO THREADS WERE VERY DAMAGED. ONLY THE METAL CORE REMAINED. SURGEON FINISHED THE SURGERY WITH REMOVING IT TO DRILL AT 4.5MM BEFORE INSERTING A NEW SCREWED ANCHOR. IN THE END, THERE ARE FOUR ANCHORS IN THE PATIENT´S HUMERUS, TWO OF THEM ARE UNNECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 11119596 ↗
• MalfunctionJan 5, 2021Break

  IT WAS REPORTED THAT DURING A REINSERTION OF THE PECTORALIS MAJOR TENDON SURGERY THE THREADS OF AR-1915SNF-1 BROKE DURING SUTURING. SURGEON WANTED TO USE CORKSCREW 3.5MM OPEN NEEDLE ANCHORS. ONE OF THE THREE ANCHORS OF THIS SIZE PLACED BROKE DURING INSERTION BETWEEN THE BODY OF THE SCREW AND THE EYELET FOR PASSING THE THREADS. WITH ONE OTHER THE TWO THREADS BROKE WHEN TIGHTENING THE KNOTS. THEN THE SURGEON TOOK THE CORKSCREW 5.5 WITH REINFORCED THREADS BUT AT THE FIRST, THE SUPPORT SCREWDRIVER BROKE BEFORE THE SCREW WAS COMPLETELY INSERTED. SURGEON TRIED TO SCREW IT IN DESPITE OF EVERYTHING BUT WITHOUT SUCCESS AND THE TWO THREADS WERE VERY DAMAGED. ONLY THE METAL CORE REMAINED. SURGEON FINISHED THE SURGERY WITH REMOVING IT TO DRILL AT 4.5MM BEFORE INSERTING A NEW SCREWED ANCHOR. IN THE END, THERE ARE FOUR ANCHORS IN THE PATIENT´S HUMERUS, TWO OF THEM ARE UNNECESSARY.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 11119542 ↗
• MalfunctionJan 5, 2021Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A REINSERTION OF THE PECTORALIS MAJOR TENDON SURGERY THE THREADS OF AR-1915SNF-1 BROKE DURING SUTURING. SURGEON WANTED TO USE CORKSCREW 3.5MM OPEN NEEDLE ANCHORS. ONE OF THE THREE ANCHORS OF THIS SIZE PLACED BROKE DURING INSERTION BETWEEN THE BODY OF THE SCREW AND THE EYELET FOR PASSING THE THREADS. WITH ONE OTHER THE TWO THREADS BROKE WHEN TIGHTENING THE KNOTS. THEN THE SURGEON TOOK THE CORKSCREW 5.5 WITH REINFORCED THREADS BUT AT THE FIRST, THE SUPPORT SCREWDRIVER BROKE BEFORE THE SCREW WAS COMPLETELY INSERTED. SURGEON TRIED TO SCREW IT IN DESPITE OF EVERYTHING BUT WITHOUT SUCCESS AND THE TWO THREADS WERE VERY DAMAGED. ONLY THE METAL CORE REMAINED. SURGEON FINISHED THE SURGERY WITH REMOVING IT TO DRILL AT 4.5MM BEFORE INSERTING A NEW SCREWED ANCHOR. IN THE END, THERE ARE FOUR ANCHORS IN THE PATIENT´S HUMERUS, TWO OF THEM ARE UNNECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 11119540 ↗