Bone Plug 6215-5-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327036671), received between Jul 3, 2018 and Jul 3, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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 16, 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 3, 2018Packaging Problem; Packaging Problem

  TWO SEPARATE BONE PLUGS WERE OPENED FOR SURGERY AND DEEMED UNSTERILE DUE TO SEAL ON PACKAGING. UPDATE (B)(6) 2018: SPOKE TO REP. THE SEAL ON THE OUTER BLISTER WAS NOT ADHERED TO THE OUTER BLISTER ALL THE WAY AROUND AND THERE WERE 'GAPS' ALLOWING AIR TO PASS IN AND OUT. THE SEAL ON THE INNER BLISTER WAS ALSO NOT ADHERED TO THE INNER BLISTER ALL THE WAY AROUND WITH THE SAME 'GAPS'. THIS HAPPENED WITH 2 DEVICES WITH 2 DIFFERENT LOTS. THE OUTER BOXES WERE DISCARDED BEFORE THE REP COULD RETRIEVE THEM. PRIMARY TKA PROCEDURE. REP WAS PRESENT IN THE OR AND WITNESSED THE EVENT. ADDITIONAL DEVICES WERE IMMEDIATELY AVAILABLE IN THE OR AND THERE WAS NO SURGICAL DELAY - THE SURGEON WAS NOT EVEN AWARE OF THE EVENT UNTIL AFTER THE PROCEDURE WAS COMPLETE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659119 ↗
• MalfunctionJul 3, 2018Packaging Problem; Packaging Problem

  TWO SEPARATE BONE PLUGS WERE OPENED FOR SURGERY AND DEEMED UNSTERILE DUE TO SEAL ON PACKAGING. UPDATE 12/JUN/2018: SPOKE TO REP. THE SEAL ON THE OUTER BLISTER WAS NOT ADHERED TO THE OUTER BLISTER ALL THE WAY AROUND AND THERE WERE 'GAPS' ALLOWING AIR TO PASS IN AND OUT. THE SEAL ON THE INNER BLISTER WAS ALSO NOT ADHERED TO THE INNER BLISTER ALL THE WAY AROUND WITH THE SAME 'GAPS'. THIS HAPPENED WITH 2 DEVICES WITH 2 DIFFERENT LOTS. THE OUTER BOXES WERE DISCARDED BEFORE THE REP COULD RETRIEVE THEM. PRIMARY TKA PROCEDURE. REP WAS PRESENT IN THE OPERATING ROOM AND WITNESSED THE EVENT. ADDITIONAL DEVICES WERE IMMEDIATELY AVAILABLE IN THE OPERATING ROOM AND THERE WAS NO SURGICAL DELAY - THE SURGEON WAS NOT EVEN AWARE OF THE EVENT UNTIL AFTER THE PROCEDURE WAS COMPLETE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658868 ↗