Aequalis Reversed II DWD167Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03700386943775), received between May 23, 2017 and Oct 24, 2024 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE HEX SCREWDRIVER BROKE OFF WHEN SCREWING THE GLENOSPHERE. A PIECE OF THE TIP GOT STUCK IN THE GLENOSPHERE AND COULD NOT BE REMOVED. LEGE ARTIS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20528229 ↗
• MalfunctionMar 5, 2024Break; Fracture; Break; Fracture

  DURING A SURGICAL PROCEDURE INVOLVING ITEM DWD194, THE DRIVER TIP DWD167 BROKE OFF INSIDE THE HEAD OF A LOCKING SCREW. A NEW DWD194 WAS OPENED AND USED, WITH A TOTAL OF 3 DWD167 TIPS USED TO COMPLETE THE SURGERY. THE SURGEON OPENED A NEW DWD167 TO REMOVE THE INITIAL SPHERE AND ANOTHER TO RE-IMPLANT THE REPLACEMENT SPHERE. THE INCIDENT OCCURRED DURING PRIMARY SURGERY, AND THERE WAS NO EXCESSIVE FORCE OR HARD BONE ENCOUNTERED.

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

  MAUDE report 18837371 ↗
• MalfunctionAug 15, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE HEX SCREWDRIVER BIT TIP BROKE INSIDE PATIENT WHEN INSERTING THE IMPLANT. THE SURGEON WAS INCAPABLE OF REMOVING THE BROKEN PIECE OF SCREW DRIVER BIT FROM THE IMPLANT. THIS RESULTED IN A 10-15 MIN SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17549230 ↗
• MalfunctionNov 16, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, WHEN THE TIP OF A SINGLE USE SCREWDRIVER USED TO PLACE THE IMPLANT BROKE OFF IN THE PATIENT AS THE DOCTOR WAS TIGHTENING THE IMPLANT INTO POSITION. THE SCREWDRIVER WAS A SINGLE USE DEVICE PROVIDED BY THE TORNIER REP. THE REP ADVISED THE DOCTOR THAT THE SCREWDRIVER TIP IS IN FACT SECURE IN PLACE IN THE IMPLANT AND WILL NOT MOVE AND THE ONLY WAY TO REMOVE IT IS TO COMPLETELY DRILL OUT THE IMPLANT. THE DOCTOR UNDERSTOOD THE SITUATION AND THEIR DECISION WAS TO LEAVE THE CURRENT IMPLANT IN PLACE WITH THE SCREWDRIVER TIP SECURED IN THE IMPLANT. THE DRILL WAS REMOVED FROM THE STERILE FIELD, LABELED, AND PLACED IN BIOHAZARD BAG THAT WAS GIVEN TO MANAGER IN SPD, WHO WAS ADVISED OF THE SITUATION WITH THE DRILL, AND THEY WERE INSTRUCTED TO CLEAN THE REMAINING PIECE FOR FURTHER FOLLOW UP.

  Patient problems: Foreign Body In Patient

  MAUDE report 15809866 ↗
• MalfunctionJul 8, 2021Break; Break

  THE TIP OF THE DRIVER BROKE OFF IN THE GLENOSPHERE. TIP COULD NOT BE FOUND & WAS LEFT IN PATIENT. ABOUT 5 MINUTES WAS ADDED TO CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12137295 ↗
• MalfunctionJun 11, 2021Break; Break

  IT WAS NECESSARY TO REMOVE THE REVERSE SHOULDER PROSTHESIS FROM THE PATIENT. AN (B)(6)YEAR-OLD WITH MILD-GRADE DIABETES THAT PRESENTED INFECTION WITH INDICATION FOR REMOVING THE PROSTHESIS. DURING THE SURGERY, ON (B)(6) 2021, THE PART OF THE HUMERUS IMPLANT WAS REMOVED WITHOUT PROBLEMS, FOLLOWED BY THE REMOVAL OF THE GLENOID IMPLANTS. AT THIS STAGE OF THE PROCEDURE, THE FOLLOWING EVENTS WERE REGISTERED: CONTAMINATION OF THE HEXAGONAL SCREWDRIVER, DWD167 AND REPLACEMENT WITH ANOTHER SCREWDRIVER OF THE SAME MODEL SUITABLE FOR FITTING. WITH THE SPARE SCREWDRIVER, THE SURGEON UNSUCCESSFULLY ATTEMPTED TO REMOVE THE GLENOID WITH NORMAL FORCE. SURGEON MADE ANOTHER ATTEMPT, NOW WITH THE GREATEST FORCE, CAUSING THE TIP OF THE SCREWDRIVER BREAK INSIDE THE ORIFICE OF THE GLENOSPHERE. THE TIP OF THE SCREWDRIVER REMAINS INSIDE THE PATIENT WITH THE ASSEMBLY OF THE GLENOSPHERE ON THE GLENOID BASE PLATE. THE DOCTOR FINISHED THE PROCEDURE WITHOUT REMOVING THE PROSTHESIS. NO, THERE WAS NO DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11986608 ↗
• MalfunctionJun 3, 2021Break; Fracture; Break; Fracture

  ON (B)(6) 2021 -THE SURGEON WAS PERFORMING A REVERSE TOTAL SHOULDER ARTHROPLASTY TODAY ON A NICKEL ALLERGY PATIENT, AND WHILE ATTEMPTING TO TIGHTEN DOWN A TITANIUM 36/25 GLENOSPHERE, A BRAND NEW 3.5 HEX DRIVER TIP BROKE OFF ONTO THE GLENOSPHERE. HE WAS ON HIS FINAL TURN WHEN THE TIP SNAPPED OFF. WE ATTEMPTED TO USE A DENTAL PICK AND A FEW DIFFERENT BURRS TO LOOSEN THE TIP, BUT NO LUCK. THE TIP OF THE HEX DRIVER WAS FLUSH INSIDE OF THE SPHERE. THE SURGEON DID NOT THINK THE GLENOSPHERE OR BASEPLATE HAD BEEN COMPROMISED AND DECIDED TO LEAVE THE TIP IN. THERE WAS NO REPORTED DELAY OR ADVERSE CONSEQUENCE. THE TIP THAT WAS LEFT IN THE GLENOSPHERE WAS VERY SMALL, IT ENDED UP BEING FLUSH.

  Patient problems: Foreign Body In Patient

  MAUDE report 11931079 ↗
• MalfunctionApr 15, 2021Break; Break

  THE TIP OF THE DRIVER BROKE OFF IN THE GLENOSPHERE. TIP COULD NOT BE FOUND & WAS LEFT IN PATIENT. ABOUT 5 MINUTES WAS ADDED TO CASE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11670394 ↗
• MalfunctionNov 6, 2020Break; Break

  AT THE MOMENT THE SURGEON FINALIZED THE FINAL TIGHTENING OF THE CENTRAL LOCKING SCREW OF THE GLENOSPHERE IN THE GLENOID PLATE, THE TIP OF THE KEY BROKE INSIDE THE HOLE, CLOSE TO THE PIECE, MAKING IT IMPOSSIBLE TO REMOVE THE BROKEN PIECE. IT WAS STUCK INSIDE THE GLENOSPHERE AND THE SURGEON COMPLETED THE IMPLANTATION OF THE REVERSE PROSTHESIS. THERE WAS NO WAY TO REMOVE THE PIECE OR THE GLENOSPHERE. WE ALSO DO NOT HAVE A GLENOID PLATE TO REVIEW IT. IT MAY IMPACT THE PATIENT IN THE FUTURE IN CASE SHE NEEDS SOME MAINTENANCE OR REPLACEMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10799897 ↗
• MalfunctionJun 28, 2019Material Deformation; Material Deformation

  VERY END OF THE SCREWDRIVER FUSED INSIDE THE GLENOSPHERES AND SHEERED. IT WAS NOT PROTRUDING AND WAS NOT MOVING/ABLE TO BE REMOVED. 5 MINUTE DELAY AS THE SURGEON TRIED TO REMOVE THE END. THE TIP REMAINED IMPLANTED. THE SURGEON WAS CONFIDENT THAT IT HAD FUSED INTO THE GLENOID SPHERE AND WOULD HAVE CAUSED DAMAGE IF WE ATTEMPTED TO GET IT OUT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8743892 ↗
• MalfunctionMay 17, 2019Material Deformation; Material Deformation

  DURING MY CASE YESTERDAY WITH DR. (B)(6) AT (B)(6) SURGERY CENTER, THE TIP OF THE ONE TIME USE HEX SCREWDRIVER, PART #DWD167 BROKE OFF INSIDE THE GLENOSPHERE, PART #DWD180 AND COLD WELDED TOGETHER. AFTER TRYING TO UTILIZE A VARIETY OF INSTRUMENTS, IT WAS DETERMINED THAT THE PART WAS UNABLE TO MOVE AND HAD TO BE LEFT INSIDE OF THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8619221 ↗
• InjuryJan 16, 2019Material Fragmentation; Material Fragmentation

  TIP OF DRIVER BROKE WHILE SCREWING IN THE BASEPLATE. THE TIP IS STILL INSIDE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8253207 ↗
• InjuryJan 29, 2018Material Deformation; Material Deformation

  PATIENT WAS IN THE OR UNDERGOING A TOTAL SHOULDER REPLACEMENT SURGERY AND WAS UNDER ANESTHESIA. GLENOID SPHERE IMPLANT WAS SECURED INTO PLACE WITH HEX SCREWDRIVER BIT. WHEN IT WAS REMOVED FROM THE IMPLANT, THE TIP REMAINED WITHIN THE INSERTION HOLE. THE PATIENT REMAINED STABLE (NO APPARENT HARM). THE SURGEON NOTED HE WAS UNABLE TO REMOVE. POST-OP X-RAYS SHOWED NO LOOSE HARDWARE AND ALL HARDWARE WAS SECURE. THE PATIENT RECOVERED WELL AND NO HARM WAS APPARENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7224182 ↗
• InjuryMay 23, 2017Material Deformation; Material Distortion; Material Deformation; Material Distortion

  THE TIP OF THE DRIVER BROKE OFF DURING USAGE. TIP IS STILL IN THE PATIENT (UNABLE TO LOCATE).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6584087 ↗