DJO SURGICAL 804-06-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912171564), received between Apr 6, 2017 and Apr 25, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INSTRUMENT FAILURE - THE KNOB ON THE STEM INSERTER ALSO BROKE OFF INTO THE STEM ONCE IT WAS IMPACTED. BROKEN FRAGMENTED PIECES LEFT IN THE PATIENT.

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

  MAUDE report 21915079 ↗
• MalfunctionFeb 24, 2022Break

  INSTRUMENT FAILURE: THE SCREW ON THE KNOB OF THE INSERTER SHEARED OFF INSIDE OF THE IMPLANTED STEM. THIS PREVENTED THE 8MM SPACER SCREW FROM BEING INSERTED INTO THE STEM. THE STEM HAD TO BE EXPLANTED AND A NEW STEM IMPLANTED TO ALLOW USE OF THE 8MM SPACER.

  Patient problems: Insufficient Information

  MAUDE report 13590900 ↗
• MalfunctionAug 23, 2021Break

  INSTRUMENT FAILURE - WHEN IMPACTING THE FINAL BROACH IN TO THE CANAL THE KNOB ON THE INSERTER BROKE AT THE "DEAD ZONE" BETWEEN THREAD PITCHES. THIS IS THE SECOND KNOB THAT HAS BROKEN DURING SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 12356062 ↗
• MalfunctionJun 2, 2021Break

  INSTRUMENT FAILURE - QUICK COUPLING T-HANDLE BROKE DURING REMOVAL OF 6.5MM BONE TAP FROM GLENOID. PATIENT HAD EXCEPTIONALLY HARD BONE AND CAUSED THE CONNECTION BETWEEN THE HANDLE" AND THE SHAFT BROKE, CAUSING "HANDLE" TO ROTATE FREELY AROUND CONNECTION TO SHAFT. THREADED IMPACTION HANDLE KNOB BROKE BETWEEN PROXIMAL AND DISTAL SCREWS DURING IMPLANT INSERTION. DISTAL PORTION OF THREADS ARE STUCK IN FINAL IMPLANT STEM. BREAK HAD NO EFFECT ON MATING BETWEEN POLY INSERT AND STEM.

  Patient problems: Insufficient Information

  MAUDE report 11919120 ↗
• MalfunctionJan 13, 2020Break

  INSTRUMENT FAILURE - DUE TO STEM INSERTER TIP KNOB SHEARING OFF DURING THE USE OF SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9582926 ↗
• MalfunctionApr 23, 2018Device Operates Differently Than Expected; Physical Property Issue

  INSTRUMENT FAILURE - DUE TO THE SCREW ON INSERTER SHEARING OFF UPON IMPACTION. REMNANT OF SCREW WAS LEFT IN HUMERAL STEM WITH NO ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7451188 ↗
• MalfunctionDec 27, 2017Break

  INSTRUMENT FAILURE - THE SURGEON WAS PERFORMING A REVERSE TOTAL SHOULDER PROCEDURE WHEN THE SCREW IN THE ALTIVATE IMPACTOR HANDLE BROKE UPON IMPACTION. THE CASE WAS WITHOUT INCIDENT UNTIL THE SURGEON IMPACTED THE STEM INTO THE HUMERUS. AS HE WAS HITTING THE IMPACT PLATE OF THE HANDLE, THE RETENTION SCREW LOOSENED, THUSLY ALLOWING ADDITIONAL FORCES TO ACT UPON THE SCREW. THE BALANCE OF THE SCREW WAS LEFT IN THE IMPLANT (530-12-108). THE SURGEON DICTATED THE INCIDENT IN HIS NOTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7147577 ↗
• MalfunctionApr 6, 2017Break; Detachment Of Device Component

  PRIMARY SURGERY - THE SURGEON WAS INSERTING THE STEM AND THE THREADS ON THE STEM INSERTER SHEARED OFF THE STEM IMPLANT. THE IMPLANT WAS WASTED FROM THIS AND A DIFFERENT STEM IMPLANT WAS USED.

  Patient problems: No Information

  MAUDE report 6464884 ↗