NA 2307-96-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295116608), received between Jun 19, 2020 and Feb 20, 2023 — classified as 3 malfunctions.

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

• MalfunctionFeb 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE GLENOSPHERE WAS INSERTED OVER GLENOSPHERE GUIDE WIRE AND WHEN THE GLENOSPHERE SCREW WAS ENGAGED INTO METAGLENE. WHEN ATTEMPTED TO PULL THE GUIDE PIN, IT WAS STUCK IN THE GLENOSPHERE. SURGEON STRUGGLED, BUT WAS ABLE TO REMOVE GUIDEWIRE. THERE WAS A 10 MINUTES OF SURGICAL DELAY. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403863 ↗
• MalfunctionMar 15, 2022Material Deformation; Material Deformation

  THE PINS ARE BENT IN THIS KIT. THE DRILL IS COMPLETELY DULL. ISSUES WERE DISCOVERED WHEN INSTRUMENTS ARRIVED TO THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771424 ↗
• MalfunctionJun 19, 2020Break; Entrapment of Device; Break; Entrapment of Device

  RESISTANCE WAS FELT WHEN THE SURGEON WAS ATTEMPTING TO REMOVE THE GLENOSPHERE GUIDEPIN BY HAND. UPON SUCCESSFUL REMOVAL OF THE GUIDEPIN USING THE TRS MODULAR DRIVE, IT WAS NOTED THAT THE REMOVED PIN IS SHORTER THAN IT¿S ORIGINAL LENGTH. UNSCREWED GLENOSPHERE TO ATTEMPT TO FIND THE BROKEN PART OF THE BIT, HOWEVER, UNABLE TO LOCATE IT. INTERVENTIONAL IMAGING DONE AND PIN SEEN ON IMAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176130 ↗