DJO SURGICAL S-201106Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00190446266068), received between Sep 15, 2021 and Dec 9, 2025 — classified as 1 injury, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Material Fragmentation; Material Integrity Problem; Material Fragmentation; Material Integrity Problem

  PATIENT PRESENTED WITH ARTHRITIS OF THE GLENOHUMERAL JOINT, IT WAS DECIDED TO INITIATE SURGERY FOR A REVERSE TOTAL SHOULDER REPLACEMENT. DURING SURGERY, THE BASEPLATE WAS IMPLANTED AND THE SHORT 4 BARREL DRILL GUIDE WAS PLACED ONTO THE BASEPLATE DURING INSERTION OF THAT INSTRUMENT (8-201106), A PORTION OF CENTRAL SCREW OF THE DRILL GUIDE BROKE OFF IN THE BASEPLATE. AFTER SEVERAL ATTEMPTS TO REMOVE THE SCREW AND THE BASEPLATE (ABOUT 25-30 MINUTES) IT WAS DETERMINED TO RELY ON THE MORSE TAPERS ON THE GLENOSPHERE AND FORGO THE RETAINING SCREW.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763846 ↗
• MalfunctionSep 12, 2022Device Handling Problem; Device Handling Problem

  INSTRUMENT FAILURE - DUE TO THE SURGEON APPLIED TOO MUCH FORCE AND THE SCREW BROKE OFF. THE BROKEN PIECE TO THE SCREW WAS LEFT IN THE BASEPLATE TO PREVENT FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403284 ↗
• MalfunctionApr 13, 2022Break

  INSTRUMENT FAILURE - SURGEON WAS ATTACHING THE TWO PIECE DRILL GUIDE TO THE BASEPLATE AND WAS NOT ABLE TO BECAUSE THE TIP OF THE SCREW BROKE OFF IN THE BASEPLATE. WHEN HE WAS PUTTING ON THE GLENOSPHERE HE WAS UNABLE TO PUT IN THE SET SCREW BECAUSE OF THE METAL PIECE. EVERYTHING FINISHED WITH NO ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 14105064 ↗
• MalfunctionSep 15, 2021Break

  PRIMARY SURGERY COMPLAINT - A HEALTH PROFESSIONAL REPORTED THAT THE CENTRAL SCREW IN THE 4-HOLE DRILL GUIDE BROKE INSIDE THE BASEPLATE MAKING IT IMPOSSIBLE TO DRILL OR INTRODUCE THE RETAINING SCREW TO SECURE THE GLENOID HEAD. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE AFTER A 10 MINUTE DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476392 ↗