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
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
- Tornier Perform MWJ127Tornier, Inc. · BIT, SURGICAL114 reports
- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.