Arthrex® AR-1927BCF-65-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867096820), received between Jul 20, 2021 and Jul 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICES BROKE INSIDE THE PATIENT AND THE BROKEN PARTS REMAINED INSIDE THE PATIENT. AS THE DEVICE IS ABSORBABLE NO REVISION SURGERY IS PLANNED. 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: Foreign Body In Patient

  MAUDE report 12198234 ↗
• MalfunctionJul 20, 2021Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICES (B)(4) (LOT 11345202) BROKE INSIDE THE PATIENT AND THE BROKEN PARTS REMAINED INSIDE THE PATIENT. AS THE DEVICE IS RESORBABLE NO REVISION SURGERY IS PLANNED. 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: Device Embedded In Tissue or Plaque

  MAUDE report 12196267 ↗