DJO SURGICAL 804-06-318Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190446839200), received between Jul 25, 2025 and Jun 3, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Mechanical Problem

  REVISION SURGERY DUE TO DISTAL END OF TAP BROKE OFF IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385996 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  INSTRUMENT FAILURE - PATIENT HAD SIGNIFICANTLY SCLEROTIC BONE. SURGEON WAS ABLE TO SUCCESSFULLY ADVANCE THE CANNULATED TAP 30MM. WHEN ATTEMPTING TO BACK THE TAP OUT OF BONE, THE INSTRUMENT BROKE ALONG THE SKINNY GUIDE WIRE PORTION, BROKEN FRAGMENTED PIECES LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24449313 ↗
• InjuryFeb 6, 2026Detachment of Device or Device Component

  INSTRUMENT FAILURE - DISPOSABLE TAP BROKE IN PATIENTS BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24285061 ↗
• MalfunctionNov 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CANNULATED TAP WAS ADVANCE OVER WIRE AND STARTED TO ADVANCE. THEN THE TAP STARTED SPINNING FREELY AND THE TIP OF THE TAP HAD BROKEN OFF INSIDE GLENOID. THE BROKEN PART WAS REMOVED BUT THIS CAUSED 20 MINUTES DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472674 ↗
• InjurySep 9, 2025Mechanical Problem; Mechanical Problem

  COMPLAINT - CANNULATED TAP BROKE OFF INTO GLENOID. THEN WHEN TRIED TO REMOVE BROKEN PART IT KEPT BREAKING INTO LIKE 15 PIECES SEEMED BRITTLE. THERE WAS A ONE AND HALF HOUR DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012362 ↗
• InjuryAug 19, 2025Mechanical Problem; Mechanical Problem

  COMPLAINT - SURGEON USED THE CANNULATED 6.5 TAP ON POWER OVER THE 2.4MM GUIDEWIRE. AS THE TAP WAS ADVANCED INTO THE BONE, WE HEARD A LOUD CRACK. THE ENTIRE TAP BROKE OFF IN THE PATIENT. THE PATIENT'S BONE WAS THE HARDEST BONE THE SURGEON HAS EXPERIENCED IN PRACTICE. THE SURGEON HAD TO USE A BROKEN SCREW REMOVAL SET TO REMOVE THE TAP. HE WAS PLANNING ON USING THE 6.5 WEDGED BASEPLATE, BUT THE HOLE BECAME TOO BIG DUE TO THE EXTRACTION. HE HAD TO USE AN 8.0 BASEPLATE, TAP, AND CENTRAL SCREW. THE FINAL OUTCOME WAS ACCEPTABLE. THERE WAS A 20-30 MINUTE DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846553 ↗
• InjuryJul 25, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INSTRUMENT FAILURE: IT BROKE, BROKEN/FRAGMENTED PIECES LEFT IN PATIENT.

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

  MAUDE report 22620388 ↗