Arthrex® SP-5068-40BBLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867221215), received between Aug 15, 2022 and Aug 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2022Break

  ON 7/27/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN SP-5068-40BBL BONEY BANKART LASSO BROKE DURING A CASE. THE SURGEON WAS PERFORMING A BONY BANKART LABRAL REPAIR OF THE LEFT SHOULDER. DURING THE PASSAGE OF SUTURE AROUND THE FRAGMENT THE TIP OF THE HOOK BROKE OFF INSIDE THE JOINT. THE IN TACT PORTION OF THE PASSER WAS REMOVED FROM THE JOINT AND THE BROKEN TIP WAS RETRIEVED AS WELL. THE CASE WAS COMPLETED SUCCESSFULLY USING A REELPASS SUTURE PASSER.

  Patient problems: Insufficient Information

  MAUDE report 15224030 ↗