NA MWB991Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03700386971006), received between Jul 28, 2017 and Jul 26, 2023 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED, THAT A SMALL SCREWDRIVER TIP BROKEN OFF. WHEN PERFORMING DOUBLE LOCKING OF SPHERE TAPER LOCK AND CENTER PIN, DURING GLENOID SPHERE PLACEMENT ON THE GLENOID FOSSA. THERE IS A LARGE POSSIBILITY OF THE FRAGMENT RESIDUAL IN THE PATIENT BODY.

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

  MAUDE report 17401912 ↗
• MalfunctionJun 5, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TIP BROKE OFF INSIDE OF THE GLENOSPHERE DURING IMPLANTATION. GLENOSPHERE WAS WELL ATTACHED. SURGEON DID NOT ATTEMPT TO REMOVE THE TIP OUT OF THE GLENOSPHERE DESPITE ENCOURAGEMENT TO DO SO.

  Patient problems: Foreign Body In Patient

  MAUDE report 17059137 ↗
• MalfunctionMay 9, 2023Break; Fracture; Break; Fracture

  DURING THE PROCEDURE FOR A SHOULDER REPLACEMENT, THE SCREWDRIVER BROKE WHILE SCREWING THE SCREW INTO THE IMPLANT. PART OF THE SCREWDRIVER GOT STUCK IN THE IMPLANT, STOPPING IT FROM BEING SCREWED IN. THE OPERATOR HAD TO USE A NEW IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 16898763 ↗
• MalfunctionMar 15, 2022Break; Fracture; Break; Fracture

  AFTER APPLYING THE GLENOSPHERE TO THE METAGLENE PLATE, A PART BROKE OFF AFTER ONE TURN OF THE SCREWDRIVER. THE PART IN QUESTION IS STUCK IN THE SCREW HOLE BELOW THE LEVEL OF THE GLENOSPHERE. ALL ATTEMPTS TO REMOVE BOTH THE BROKEN PART AND THE ENTIRE GLENOSPHERE FAILED. THE GLENOSPHERE WAS SOLIDLY WELDED. THERE WAS A DELAY IN SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13776713 ↗
• MalfunctionApr 14, 2021Break; Break

  WHEN INSERTING THE GLENOSPHERE THE DRIVER SNAPPED. EXCESSIVE FORCE WAS NOT USED. THE DRIVER HEAD WAS INSIDE THE GLENOSPHERE AND AFTER 5 MIN OF USING THE FRASER SUCKER AN X-RAY WAS CALLED TO CONFIRM IF IT WAS OUT. X RAY OF THE PATIENT SHOWED NO SIGN OF DRIVER HEAD. DR MACLEAN X RAYED THE SUCKER BAG AND THE DRIVER TIP WAS INSIDE. CONFIRMATION OF THE DRIVER TIP BEING OUT OF THE PATIENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11663380 ↗
• MalfunctionApr 8, 2021Break; Break

  DURING SURGERY THE TIP OF THE SCREWDRIVER BROKE OFF IN THE PATIENT'S GLENOSPHERE. THE TIP WAS FIRMLY EDGED IN THE GLENOSPHERE AND THE TIP WAS FLUSH. THE TIP WAS LEFT INSIDE THE PATIENT AS IT COULDN'T BE REMOVED DESPITE SEVERAL ATTEMPTS USING DIFFERENT METHODS BY THE SURGEON (FRAZIER SUCKER, DENTAL PICK, DRILLING AND BURRING). AS A PRECAUTION THE SURGEON PLACED BONE WAX IN THE HOLE IN THE GLENOSPHERE OVER THE BROKEN TIP TO PREVENT THE PIECE MOVING IF IT CAME LOOSE LATER. THE SURGEON HAS REQUESTED ADVICE FROM THE MANUFACTURER AS TO WHETHER THERE IS ANY WAY TO REMOVE THE BROKEN SCREWDRIVER TIP IF THE PATIENT REQUIRES A FUTURE REVISION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11633045 ↗
• MalfunctionJan 6, 2021Break; Break

  DURING THE SURGICAL PROCEDURE, THE SURGEON (B)(6) IMPLANTS THE 10 ° TILTED SPHERE, THE MEDICAL DEVICE IS CORRECTLY POSITIONED ON THE BASE PLATE. WHEN THE SURGEON WAS FINISHING SCREWING THE GLENOID SPHERE TO THE BASE PLATE WITH THE 3.5MM HEXAGONAL SCREWDRIVER (REFERENCE MWB991, LOT 19B815) THE TIP OF THE SCREWDRIVER BROKE, LEAVING THE FRAGMENT WITHIN THE HEXAGON OF THE GLENOID SPHERE SCREW. THE SURGEON TRIED FOR 15 MINUTES TO REMOVE THE FRACTURED TIP OF THE SCREWDRIVER FROM THE GLENOID SPHERE WITHOUT SUCCESS. SURGEON (B)(6), OBSERVING THAT THIS FRAGMENT REMAINED FIXED AND CANNOT BE REMOVED, DECIDES TO LEAVE IT WITHIN THE HEXAGON OF THE GLENOID SPHERE. THE SURGERY ENDS WITHOUT FURTHER SERIOUS EVENTS AND THE PATIENT DOES NOT PRESENT SERIOUS PROBLEMS OR IMPACTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11122702 ↗
• InjuryApr 25, 2019Material Fragmentation; Material Fragmentation

  TIP OF THE SCREWDRIVER BROKE WHILE POSITIONING THE GLENOSPHERE. IF BROKEN PART IN THE HOLE AND IN THE PATIENT IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 8548916 ↗
• InjuryApr 4, 2019Material Fragmentation; Material Fragmentation

  TIP OF THE SCREWDRIVER BROKE WHILE POSITIONING THE GLENOSPHERE. BROKEN PART IN THE HOLE AND IN THE PATIENT WITH NO POSSIBILITY TO EXTRACT.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 8482417 ↗
• InjuryMar 15, 2019Material Fragmentation; Material Fragmentation

  HEXAGONAL TIP BROKE INSIDE THE GLENOSPHERE.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 8424697 ↗
• InjuryMar 15, 2019Material Fragmentation; Material Fragmentation

  HEXAGONAL TIP BROKE INSIDE THE GLENOSPHERE. SURGERY WAS COMPLETED WITHOUT DELAY.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 8424696 ↗
• InjuryJul 28, 2017Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  DURING THE SURGERY WHEN THE SURGEON REQUESTED THE GLENOID SPHERE FOR IMPLANTATION, REFERENCE (B)(4) SERIAL NUMBER (B)(4), THE MEDICAL DEVICE HAD THE SCREW BLOCKED, PREVENTING ITS PROPER IMPLEMENTATION TO THE BASE PLATE. THE SURGEON TRIED SEVERAL TIMES TO RELEASE THE SCREW UNTIL THE 3.5 MM HEXAGONAL SCREWDRIVER TIP BROKE. THE DOCTOR TRIED TO IMPLANT OTHER SPHERE (B)(4) SERIAL NUMBER (B)(4)WITH A NEW 3.5 MM HEXAGONAL SCREWDRIVER BUT HAD THE SAME PROBLEM AND THE 3.5 MM HEXAGONAL SCREWDRIVER TIP BROKE AGAIN.

  Patient problems: Failure of Implant; Patient Problem/Medical Problem

  MAUDE report 6749745 ↗
• InjuryJul 28, 2017Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  DURING THE SURGERY WHEN THE SURGEON REQUESTED THE GLENOID SPHERE FOR IMPLANTATION, REFERENCE(B)(6), SERIAL NUMBER (B)(4), THE MEDICAL DEVICE HAD THE SCREW BLOCKED, PREVENTING ITS PROPER IMPLEMENTATION TO THE BASE PLATE. THE SURGEON TRIED SEVERAL TIMES TO RELEASE THE SCREW UNTIL THE 3.5 MM HEXAGONAL SCREWDRIVER TIP BROKE. THE DOCTOR TRIED TO IMPLANT OTHER SPHERE (B)(6), SERIAL NUMBER (B)(4) WITH A NEW 3.5 MM HEXAGONAL SCREWDRIVER BUT HAD THE SAME PROBLEM AND THE 3.5 MM HEXAGONAL SCREWDRIVER TIP BROKE AGAIN.

  Patient problems: Failure of Implant; Patient Problem/Medical Problem

  MAUDE report 6749744 ↗