Shoulder Instruments 04.01.10.0421Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630971238176), received between Mar 12, 2019 and May 8, 2019 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2019Break; Break

  DURING THE SURGERY THE GLENOSPHERE NITINOL GUIDE BROKE AT WIRE-INSTRUMENT METAL SHAFT CONNECTION LEVEL. THE SURGERY WAS COMPLETED SUCCESSFULLY AND WITHOUT DELAY USING THE STANDARD GUIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591160 ↗
• MalfunctionMar 14, 2019Break; Break

  DURING THE PRIMARY SHOULDER SURGERY AND UPON INSERTING THE GLENOSPHERE, THE GLENOSPHERE GUIDE WITH NITINOL BROKE AND A FRAGMENT REMAINED INTO THE GLENOSPHERE. THE SURGEON REMOVED THE GLENOSPHERE, REMOVED THE BROKEN FRAGMENT FROM THE GLENOSPHERE AND USED GENERAL INSTRUMENTATION TO RE-INSERT THE GLENOSPHERE. THERE WAS A 10 MINUTES DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8421116 ↗
• MalfunctionMar 12, 2019Material Fragmentation; Material Fragmentation

  THE GLENOSPHERE NITINOL GUIDE - BODY BROKE OFF DURING SURGERY. THIS WAS A LARGE MALE PATIENT WITH A VERY TIGHT SHOULDER WHICH MADE REDUCING THE GLENOSPHERE ON TO THE MORSE TAPER OF THE BASEPLATE DIFFICULT, EVEN WITH THE ASSISTANCE OF THE NEW GUIDE WIRE. NO METAL FRAGMENT FOUND ON X-RAY, THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412846 ↗