Shoulder System Instrument 04.01.10.0094Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971210301), received between Feb 6, 2020 and Aug 3, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionAug 3, 2023Fracture; Material Deformation; Fracture; Material Deformation

  DURING THE PRIMARY SHOULDER, WHEN THE SURGEON WAS IMPACTING THE GLENOSPHERE, 2 FLEXIBLE WIRES BROKE (NEAR THE BASE OF THE WIRE) AND 2 GLENOSPHERE GUIDES BENT. THE SURGEON HAD TO DISIMPACT THE HEAD AND HAD TO ABANDON THE POST ALTOGETHER AND PUT THE GLENOSPHERE ON WITHOUT A POST. HE WAS ABLE TO IMPACT IT ONTO THE GLENOID BASEPLATE, BUT AT AN ODD ANGLE THAT ENGAGED THE MORSE TAPER PARTIALLY. THEREFORE THE POST COULD NOT BE PULLED OUT. THERE WAS A 2-HOUR DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A LOANER SET WAS UTILIZED AND ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17448630 ↗
• MalfunctionFeb 6, 2020Material Deformation; Material Deformation

  DURING THE PRIMARY SHOULDER SURGERY, WHILE PUTTING ON THE GLENOSPHERE, IT WAS OBSERVED THAT THE GLENOSPHERE GUIDES WERE DAMAGED ON THE PROXIMAL END AROUND THE HEX RECESS. ONE GUIDE WAS DAMAGED TO THE POINT THAT THE SCREWDRIVER WOULD NOT FIT IN. THE SECOND GUIDE WAS NOT USEABLE AS IT WOULD PUSH THE GLENOSPHERE OFF THE TAPER WHEN TRYING TO EXTRACT THE GUIDE. THE AGENT HAD A SECOND REVERSE TRAY AVAILABLE, AND THE GUIDES IN THAT TRAY SEEMED SUFFICIENT INITIALLY, BUT THE SURGERY COULD NOT GET THE GLENOSPHERE TO SLIDE OVER THE GUIDE AT ALL. IT WAS OBSERVED THAT THESE GUIDES WERE TOO BRADDED AT THE TOP AND THE LAST 2MM OF THE GUIDE WERE TOO LARGE FOR THE GLENOSPHERE TO FIT OVER. THE SURGEON COMPLETED THE CASE WITHOUT THE GUIDES AND USED A RETAINMENT SCREW TO HELP IMPLANT THE GLENOSPHERE. THERE WAS A 3-HOUR DELAY IN THE CASE. ADDITIONAL ANESTHESIA HAD TO BE ADMINISTERED. THE GUIDES CAME FROM LOANER SETS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9675478 ↗