DJO SURGICAL 804-03-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912148177), received between Dec 3, 2016 and Jul 3, 2024 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024No Apparent Adverse Event; No Apparent Adverse Event

  PRIMARY SURGERY: BASEPLATE WOULD NOT ACCEPT GLENOSPHERE LOCKING SCREW.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19672426 ↗
• MalfunctionFeb 24, 2022Break

  INSTRUMENT FAILURE - THE SET SCREW IN THE INSTRUMENT ASSEMBLY BROKE OFF IN THE BASEPLATE. SURGEON WAS ABLE TO REMOVE THE BASE PLANT AND IMPLANTED A NEW BASEPLATE.

  Patient problems: Insufficient Information

  MAUDE report 13590889 ↗
• MalfunctionJan 24, 2022Break

  INSTRUMENT FAILURE - THE SET SCREW BROKE OFF IN THE IMPLANTED BASEPLATE. SURGEON SECURED THE GLENOSPHERE IMPLANT TO THE BASEPLATE WITH THE MORSE TAPER BUT WAS UNABLE TO IMPLANT THE RETAINING SCREW BECAUSE THE INSTRUMENT BROKE OFF IN THE BASEPLATE.

  Patient problems: Insufficient Information

  MAUDE report 13338220 ↗
• MalfunctionJun 10, 2021Break

  INSTRUMENT FAILURE: THE PIECE OF DRILL GUIDE THAT THREADS INTO THE GLENOID BASEPLATE TO HOLD THE GUIDE IN PLACE, BROKE OFF INTO THE BASEPLATE. SURGEON HAD TO REMOVE THE BASEPLATE WITH PLIERS AND WE HAD TO OPEN A NEW BASEPLATE. NO METAL PIECES REMAINED IN THE PATIENT. THE METAL PIECE BROKE OFF IN THE IMPLANT. AND THE IMPLANT WAS REMOVED FROM THE PATIENT AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 11979158 ↗
• MalfunctionMay 26, 2021Detachment of Device or Device Component

  INSTRUMENT FAILURE - DURING A REVISION SURGERY OF A STRYKER TOTAL SHOULDER TO A DJO REVERSE SHOULDER THE SET SCREW FOR THE 4-IN-1 DRILL GUIDE SHEERED OFF IN THE GLENOID BASEPLATE IMPLANT. DUE TO THIS HAPPENING, THE GLENOID RETAINING SCREW COULD NOT BE UTILIZED. IT WAS DETERMINED THAT THE LACK OF TYPICAL EXPOSURE WAS THE CAUSE OF THIS INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 11882809 ↗
• MalfunctionApr 30, 2021Break

  INSTRUMENT FAILURE - DUE TO SCREW IN THE DRILL GUIDE BROKE OFF IN THE REVERSE SHOULDER PROSTHESIS BASEPLATE (508-32-204). THE SURGEON HAD TO REMOVE THE IMPLANTED BASEPLATE AND REPLACE IT WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 11758004 ↗
• MalfunctionJan 25, 2021Break

  INSTRUMENT FAILURE - DURING REVERSE WITH SURGEON THE GUIDE FOR THE PERIPHERAL SCREWS BROKE. THE CENTRAL SCREW BROKE INSIDE THE BASEPLATE BELOW THE SURFACE. HAD TO PULL BASEPLATE, WASTED IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 11225162 ↗
• MalfunctionSep 16, 2020Break

  INSTRUMENT FAILURE - THE SURGEON WAS APPLYING THE BASEPLATE DRILL GUIDE TO THE IMPLANTED BASEPLATE IN ORDER TO PREPARE FOR THE BASEPLATE SCREWS. THE GUIDE WAS PLACED ON THE BASEPLATE AND THE CENTER HOLDING SCREW WAS TIGHTENED. UPON TIGHTENING THE SCREW, EVERYONE HEARD A SNAP. IT WAS DISCOVERED THAT THE TIP OF THE SCREW HAD BROKEN OFF INSIDE THE BASEPLATE. THERE WAS ENOUGH DEPTH TO BACK THE BASEPLATE OUT WITH THE SCREWDRIVER BUT THE REMAINING TIP WAS GOING TO IMPEDE THE GLENOSPHERE SCREW FROM SEATING. HE REMOVED THE BASEPLATE AND A NEW ONE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 10540776 ↗
• MalfunctionFeb 3, 2020Loose or Intermittent Connection; No Apparent Adverse Event; No Apparent Adverse Event

  INSTRUMENT FAILURE - CROSS THREADED SCREW FROM 4 HOLE DRILL GUIDE, RETAINING SCREW FOR GLENOSPHERE WOULD NOT LOCK IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9660945 ↗
• MalfunctionJan 23, 2020Break; No Apparent Adverse Event; No Apparent Adverse Event

  INSTRUMENT FAILURE - DUE TO RETAINING SCREW FOR GLENOSPHERE BROKE OFF IN BASEPLATE DUE TO CROSS THREADED SCREW FROM 4 HOLD DRILL GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9623392 ↗
• InjuryFeb 28, 2019Break; Detachment of Device or Device Component

  REPORTED INCIDENT - WHILE TRYING TO ENGAGE THE GUIDE INTO THE BASEPLATE, THE TIP BROKE OFF INSIDE THE BASEPLATE. THE TIP WAS LEFT IN THE PATIENT, PART OF ITEM WILL BE RETURNED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8379875 ↗
• MalfunctionAug 31, 2018Break; Detachment of Device or Device Component

  INSTRUMENT FAILURE - THE CENTER THREADED PIECE OF THE DRILL GUIDE, THAT THREADS INTO THE BASEPLATE, BROKE OFF IN THE BASEPLATE DURING SURGERY. THE SURGEONS HAD TO REMOVE THE BASEPLATE WITH PLIERS AND PUT IN A NEW BASEPLATE. NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839693 ↗
• MalfunctionDec 19, 2017Break

  INSTRUMENT FAILURE - THE REVERSE SHOULDER PROSTHESIS (RSP) GLENOID DRILL GUIDE BROKE OFF INTO THE REVERSE SHOULDER PROSTHESIS (RSP) GLENOID BASEPLATE. THE THREADS SHEARED OFF INTO THE COMPONENT. BASEPLATE BEING RETURNED UNDER (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7131246 ↗
• MalfunctionDec 22, 2016Break

  INSTRUMENT FAILURE - DUE TO THE DRILL GUIDE BREAKING IN THE BASEPLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6200537 ↗
• MalfunctionDec 3, 2016Break

  INSTRUMENT FAILURE - DUE TO THE BOLT THAT FIXATES THE REVERSE SHOULDER PROSTHESIS (RSP) DRILL GUIDE, 804-03-048, INTO THE BASEPLATE BROKE OFF INSIDE THE BASEPLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6143762 ↗