Shoulder System Instrument 04.01.10.0050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630971233805), received between Feb 20, 2025 and Sep 1, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543248 ↗
• MalfunctionMay 8, 2026Fracture

  DURING THE PROCEDURE, THE DRILL BIT BROKE, RESULTING IN A SIGNIFICANT DELAY IN THE PROCEDURE (APPROXIMATELY 3 HOURS OVER 4 HOURS AND 30 MINUTES OF SURGERY) DUE TO DIFFICULTY IN REMOVING THE TIP PIECE RETRIEVED AND SURGERY COMPLETED SUCCESSFULLY. THE DRILL GUIDE WAS USED. THE PATIENT`S BONE WAS EXTREMELY SCLEROTIC, WHICH LED TO OVERHEATING OF THE DRILL BIT AND REQUIRED GREATER FORCE FOR DRILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123194 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  THE DRILL BIT FOR GLENOID POLYAXIAL SCREWS BROKE AND REMAINED IN THE GLENOID. THE SURGEON INSERTED A SMALLER SCREW TO AVOID INTERFERENCE WITH THE POLYAXIAL SCREW. YOUNG PATIENT, BONE WAS NOT SCLEROTIC; 5 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687571 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  THE DRILL BIT FOR GLENOID POLYAXIAL SCREWS BROKE AND REMAINED IN THE GLENOID. THE SURGEON INSERTED THE SCREW IN A DIFFERENT DIRECTION THAN THE DRILL. 5 MIN DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685764 ↗
• MalfunctionMar 7, 2025Fracture; Fracture

  THE DRILL BIT BROKE DURING THE DRILLING OF THE SUPERIOR POLYAXIAL SCREW. DRILL GUIDE WAS USED (04.01.10.0274, LOT 2159295; 04.01.10.0034, LOT 2253841). IMMEDIATELY THE OPERATION WAS STOPPED AND C-ARM DEVICE WAS APPLIED TO IDENTIFY THE POSITION OF THE BROKEN DRILL'S BIT AT THE PATIENT'S BODY. AT THE RADIOLOGICAL EXPOSURE, WAS SEEN THAT THE REMAINING PART OF THE BROKEN DRILL WAS TRAPPED IN THE CHEST, BUT NOT TO THE POINT OF CAUSING ANY VITAL PROBLEMS, ACCORDING TO THE OPINION OF A THORACIC SURGEON WHO WAS CALLED IN TO ASSESS THE SITUATION. THE OPERATION WAS CONTINUED AND COMPLETED SUCCESSFULLY (SUPERIOR AND INFERIOR SCREWS PLACED) AND WITH A VERY GOOD INTRAOPERATIVE OUTCOME IN TERMS OF JOINT'S STABILITY AND PASSIVE RANGE OF MOTION. THE SURGERY WAS EXTENDED BY ABOUT 1.5 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547225 ↗
• MalfunctionFeb 20, 2025Fracture; Fracture

  DURING THE SHOULDER PROSTHESIS SURGERY, THE DRILL BIT FOR POLYAXIAL SCREWS BROKE WHILE DRILLING IN THE GLENOID. A BROKEN PIECE REMAINED INSIDE THE PATIENT. DRILL GUIDE USED. SURGERY COMPLETED WITH ABOUT 10/15 MIN DELAY, TOT TIME SURGERY ABOUT 2.5 HOURS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21418877 ↗