Skip to content

Tornier Perform MWJ126Recalls & reported problems

Tornier, Inc. · Peripheral Screw Drill Bit · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832062089), received between Jun 28, 2024 and Sep 23, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Fracture2

Patient problems

  • Foreign Body In Patient1
  • Insufficient Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 23, 2025Break; Fracture; Break; Fracture

    IT WAS REPORTED THAT DURING A SCHEDULED LEFT REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY, THE SURGEON IDENTIFIED A RETAINED FRAGMENT OF A DRILL BIT NEAR THE POLY HUMERAL HEAD LINER ON INTRAOPERATIVE X-RAY IMAGING. THE SURGEON SUBSEQUENTLY REOPENED THE SURGICAL SITE TO REMOVE THE DRILL BIT FRAGMENT AND REPLACED THE POLY HUMERAL HEAD LINER. THE PROCEDURE EXCEEDED THE PLANNED SURGICAL TIME BY APPROXIMATELY 90 MINUTES. THE REVISION WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA RECOVERY UNIT IN STABLE CONDITION.

    Patient problems: Insufficient Information

    MAUDE report 23126446 ↗
  • InjuryJun 28, 2024Break; Fracture; Break; Fracture

    AS REPORTED: "STERILE DISPOSABLE DRILL (B)(6) BROKEN DURING DRILLING. BROKEN TIP COULD NOT BE RECOVERED. NEW ITEM (B)(6) WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY."

    Patient problems: Foreign Body In Patient

    MAUDE report 19634401 ↗

Other BIT, SURGICAL devices

All BIT, SURGICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.