Tornier Perform MWJ111Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00846832062348), received between May 10, 2021 and May 8, 2026 — classified as 1 injury, 9 malfunctions.

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

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Fracture

  DRILL BIT BROKE DURING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128212 ↗
• MalfunctionApr 28, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A 6.5 CENTRAL DRILL BROKE DURING A PRIMARY SURGERY. NO OTHER INSTRUMENTS OR IMPLANTS WERE USED IN COMBINATION WITH THE AFFECTED INSTRUMENT. ALL DEBRIS WAS REMOVED FROM THE FIELD. THIS DRILL IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922029 ↗
• MalfunctionFeb 19, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED DURING INBOUND INSPECTION FOLLOWING A PRIMARY SURGERY THAT A 6.5MM CENTRAL SCREW DRILL TIP WAS BROKEN. THERE WAS NO REPORTED PRESENCE OF HARD BONE OR DEBRIS. THE SCREW DRILL HAD BEEN IN SERVICE FOR OVER FIVE YEARS. THE DEVICE WAS INSPECTED PRIOR TO BEING SENT TO THE CUSTOMER. A TRACKING NUMBER WAS PROVIDED FOR ITS RETURN TO THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412889 ↗
• MalfunctionAug 22, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A HANDLE BROKE OFF, AND THE TIP BROKE WHILE THE DOCTOR WAS DRILLING. ALL BROKEN PIECES WERE RECOVERED, AND THE ITEM WAS DISCARDED IMMEDIATELY AFTER THE INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 20029577 ↗
• InjuryNov 1, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE PATIENT WAS UNDERGOING A PERFORM STEM AND PERFORM REVERSED TOTAL SHOULDER PROSTHESIS, HAD A HIGH BONE DENSITY AND A SCLEROTIC GLENOID, WHICH HAD PREVIOUSLY TWISTED THE THREADED SPINDLE, FOR GLENOID AIMING GUIDANCE. DURING DRILLING OF THE CENTRAL SCREW OF THE PERFORM REVERSED BASEPLATE, THE 6.5-DIAMETER WIRE, REF MWJ111, BROKE OFF, LEAVING 2/3 OF IT IN THE PATIENT'S GLENOID. THE SURGEON WAS UNABLE TO REMOVE THE DEBRIS, AND INSERTED A SHORT 7MM STUD IN PLACE OF THE 6.5X25 CENTRAL SCREW INITIALLY CHOSEN. THE OPERATION WAS COMPLETED WITHOUT DIFFICULTY."

  Patient problems: Foreign Body In Patient

  MAUDE report 18047188 ↗
• MalfunctionSep 19, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DRILL BROKE OFF INSIDE THE PATIENT AND COULD NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17777293 ↗
• MalfunctionJun 29, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE CENTRAL SCREW BROKEN DURING SURGERY. THE CUSTOMER HAD A DRILL FROM ANOTHER COMPANY AVAILABLE AS A SUBSTITUTE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851278 ↗
• MalfunctionMar 3, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SURGEON DRILLED FOR 6.5MM CENTRAL SCREW AND NOTICED THE END OF THE DRILL WAS BROKEN AFTER USE. THE TIP OF THE DRILL WAS LODGED IN THE BONE BUT THE SCREW PLACEMENT WAS SUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13659707 ↗
• MalfunctionOct 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE DISTAL PART OF THE DRILL FOR THE CENTRAL SCREW BROKE OFF DURING GLENOID PREPARATION LEAVING A PART WITHIN THE PATIENT'S GLENOID.

  Patient problems: Foreign Body In Patient

  MAUDE report 12585236 ↗
• MalfunctionMay 10, 2021Break; Break

  ALLEGEDLY, THE SURGEON IDENTIFIED THROUGH X-RAY THAT THERE WAS SOMETHING IN THE PATIENT'S BONE RESEMBLING A TIP OF A DRILL BIT. UPON A SEARCH IN STERILE PROCESSING THE DRILL WAS LOCATED AND THE DRILL IS MISSING THE TOP PORTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 11803706 ↗