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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867022669), received between Dec 19, 2016 and Feb 12, 2020 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PATELLAR TENDON SUTURE THE METAL TIP BROKE OFF INSIDE THE PATIENT. THE SURGEON TRIED TO RETRIEVE THE PART OUT OF THE PATIENT BUT WAS NOT SUCCESSFUL. THE PIECE REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9700828 ↗
• InjuryAug 6, 2019Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY WHEN SCREWING IN THE ANCHOR BROKE. THE BROKEN PIECE WAS NOT REMOVED FROM PATIENT. IT REMAINS. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE 23-JUL-2019: THE REMAINING PART IS FIXED WELL IN PATIENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8865934 ↗
• InjuryFeb 13, 2018Material Fragmentation

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING INSERTION. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN FRAGMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. THERE WAS NO HARM FOR PATIENT, USER OR THIRD PARTY. PERFORMED SURGERY WAS AN ARTHROSCOPIC BICEPS TENODESIS.

  Patient problems: No Code Available

  MAUDE report 7266944 ↗
• InjuryDec 19, 2016Break

  IT WAS REPORTED THAT ANCHOR BROKE DURING INSERTION IN THE PROXIMAL PATELLA. SURGERY PERFORMED WAS AN ACL AND QUADRICEPS TENDON RE-FIXATION. FRAGMENT COULD NOT BE RETRIEVED AND REMAINS IN PATIENT'S BODY. SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME PART NUMBER. ACCORDING TO SURGEON, FRAGMENT DOES NOT AFFECT PATIENT NEGATIVELY, FRAGMENT IS NOT PROMINENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6184916 ↗