Shoulder System 04.01.0162Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630040706490), received between May 11, 2018 and Jul 2, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Fracture; Fracture

  THE PRONGS OF THE SCREW BROKE AND THE SCREW COULD NOT BE REMOVED FROM THE BONE. TOTAL SURGERY TIME WAS 3 HOURS, AND THE DELAY TIME WAS 20 MINUTES. THE SURGEON THINKS THAT THE FOLLOWING SEQUENCE HAPPENED: THE FIRST SCREW WAS PARTIALLY INSERTED, FOLLOWED BY FULL INSERTION OF THE SECOND SCREW. WHEN AN ATTEMPT WAS MADE TO FURTHER ADVANCE THE FIRST SCREW, IT DID NOT MOVE AND THE SCREW HEAD FRACTURED. IT IS PRESUMED THAT THE FIRST SCREW MAY HAVE ENGAGED HARD CORTICAL BONE, AND THE INSERTION OF THE SECOND SCREW CAUSED THE FIRST SCREW TO BEND OR BECOME MISALIGNED, RESULTING IN IT BECOMING STUCK AND EVENTUALLY LEADING TO THE SCREW HEAD FAILURE. TWO SCREWS WERE USED FOR THE BASEPLATE, THE INFERIOR IS THE BROKEN ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22380968 ↗
• InjuryFeb 23, 2024Fracture; Fracture

  DURING THE PRIMARY SHOULDER SURGERY, ONE OF THE GLENOID POLYAXIAL SCREW BROKE DURING THE INITIAL INSERTION (04.01.10.0281 USED). THE SURGEON TRIED TO BACK IT OUT OR SEAT IT ALL THE WAY, BUT EVENTUALLY DECIDED TO CUT THE SCREW OFF AND BREAK IT DOWN AND WAS ABLE TO SEAT THE GLENOSPHERE. THERE WAS A 40-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. FOUR GLENOID POLYAXIAL LOCKING SCREWS WERE PLACED: 34MM SUPERIOR (BROKEN), 14MM ANTERIOR, 14MM POSTERIOR, 26MM INFERIOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18766812 ↗
• MalfunctionOct 27, 2023Material Deformation; Material Deformation

  DURING THE SURGERY, THE PRONGS OF TWO GLENOID POLYAXIAL SCREWS WERE DEFORMED, DURING THE INSERTION PHASE WHILE USING THE GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE. THE BONE WAS HARD. THE GLENOID POLYAXIAL LOCKING SCREW - L26 WAS REPLACED WITH ANOTHER SCREW, WHILE THE GLENOID POLYAXIAL LOCKING SCREW - L34 WAS REAMED DOWN WITH AIRTOME CUTTER. DELAY TIME WAS 40 - 50 MIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18019680 ↗
• MalfunctionDec 13, 2022Break; Break

  DURING PRIMARY SURGERY, DURING GLENOID PREPARATION, THE DRILL BIT FOR POLYAXIAL SCREW BROKE AND THE BROKEN PIECE WAS LEFT IN THE PATIENT BONE. THEN, WHEN INSERTING THE ANTERIOR POLYAXIAL LOCKING SCREW L34, ONE OF THE PRONG BROKE. PLACEMENT OF THE SCREWS WAS DONE USING SCREWDRIVER. IN THE ATTEMPT OF REMOVING THE SCREW WITH A COMPETITOR REMOVAL DEVICE, THE TIP OF REMOVAL DEVICE BROKE INSIDE THE SCREW, THEREFORE THE SCREW HAD TO BE LEFT IN THE PATIENT. THE PART OF THE SCREW PROTRUDING FROM THE BASEPLATE WAS CUT OFF WITH PLIERS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30-MINUTES DELAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15969314 ↗
• MalfunctionJun 21, 2019Material Fragmentation; Material Fragmentation

  THE SURGEON, AT THE TIME OF SCREW FIXATION, FOUND THAT THE SMALL GLENOID POLYAXIAL SCREW HEAD BROKE. THE SURGEON COMMENTED THAT THE SCREW WAS IN AXES AND THE CORRECT INSTRUMENT WAS USED DURING SURGERY SO HE LEFT THE SCREW IN PLACE. THE HEAD OF THE SCREW WAS LOST DURING SURGERY, X-RAYS POST OP DO NOT SHOW ANY SCREW HEAD IN THE AREA. NO DELAY REPORTED DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8721537 ↗
• InjuryApr 29, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY SURGERY THE HEAD OF THE SCREW GOT DAMAGED WHEN THE SURGEON TRIED TO INSERT IT WITH THE SCREWDRIVER. THE SCREW WAS FURTHER DAMAGED EXTRACTING IT WITH A PINCER. THE BONE WAS SCLEROTIC. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NEW SCREW. NO CRITICAL DELAY DURING THE SURGERY AND NO PARTS FELL INTO THE PATIENT. THE "GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE" (REF. (B)(4)) WAS USED TO INSERT THE SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560456 ↗
• MalfunctionMay 11, 2018Bent; Entrapment of Device

  DURING THE GLENOID POLYAXIAL LOCKING SCREW INSERTION SOME PRONGS OF THE OUTER SCREW WERE BENT. THE OUTER SCREW REMAINED STUCK IN THE BASEPLATE AND IT COULD NOT BE REMOVED, THE SURGEON REMOVED ALL SCREW PRONGS, USING PLIERS, AND COMPLETE THE SURGERY SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7506729 ↗