Tornier Perform MWJ127Recalls & reported problems
Tornier, Inc. · Peripheral and Sphere Screwdriver Bit · Class 1
All models of Tornier Perform (40)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Tornier Perform screwdriver bit has 129 adverse event reports on record, with no deaths and 3 injuries. The reports mostly describe the bit fracturing or its tip breaking off while tightening screws, and a few mention fragments left in the patient. Most say no clinical signs were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 114
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00846832062492), received between May 6, 2021 and Sep 29, 2026 — classified as 3 injuries, 111 malfunctions.
The most frequently reported specific device problem is “Fracture” (111 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture111
- Break65
- Material Twisted/Bent7
- Material Deformation2
- Material Erosion1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions108
- Insufficient Information6
- Foreign Body In Patient3
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50935307 ↗MalfunctionSep 17, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809706 ↗MalfunctionJul 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074249 ↗MalfunctionJul 27, 2026Fracture
As reported: "Found tip of driver to be sheared off."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046410 ↗MalfunctionJul 9, 2026Fracture; Material Deformation
Screwdriver bits were warped or broken.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25764165 ↗MalfunctionJul 7, 2026Fracture; Material Twisted/Bent
IN A REVISION, THE SURGEON WAS TRYING THE ADVANCE THE CENTRAL SCREW IT THE POLY USING BOTH DRIVERS. IN THE PROCESS THE BOTH DRIVERS WERE BROKE/BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25737265 ↗InjuryJun 9, 2026Fracture
DURING A REVERSE SHOULDER ARTHROPLASTY THE SCREWDRIVER TIP (MWJ127) BROKE AND SNAPPED OFF INSIDE THE GLENOSPHERE WHEN TIGHTENING THE GLENOSPHERE SCREW. THE TIP WAS BURIED AND STUCK IN THE SCREW HEAD OF THE GLENOSPHERE SO REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 25446813 ↗MalfunctionJun 9, 2026Fracture
T20 DRIVER TIP BROKE OFF IN PERFORM SPHERE EXTRACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446809 ↗MalfunctionJun 2, 2026Fracture
IT WAS REPORTED THAT THE DRIVER BROKE DURING A CASE AND IS UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25362349 ↗MalfunctionMay 13, 2026Fracture
IT WAS REPORTED THAT DURING A PRIMARY SURGERY THE TORNIER DRIVER FOR THE RATCHETING HANDLES HIP BROKE OFF WHILE INSERTING A SCREW, EVERYTHING WAS RECOVERED NO ISSUES. THE REMAINING SCREWS WERE INSERTED WITH ANOTHER SCREWDRIVER. THE DURATION OF THE SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162473 ↗MalfunctionMay 12, 2026Fracture
DRIVER TIP BROKE DURING PROCEDURE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151401 ↗MalfunctionMay 12, 2026Fracture
DRIVER TIP BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151400 ↗MalfunctionMay 12, 2026Fracture
DRIVER TIP BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151390 ↗MalfunctionMay 12, 2026Fracture
DRIVER TIP BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150722 ↗MalfunctionMay 12, 2026Fracture
DRIVER TIP BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150678 ↗MalfunctionMay 12, 2026Fracture
DRIVER TIP BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150677 ↗MalfunctionMay 12, 2026Fracture
DRIVER TIP BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150527 ↗MalfunctionMay 5, 2026Fracture
IT WAS REPORTED THAT THE SCREWDRIVER TIP WAS BROKEN DURING PLACEMENT OF PERIPHERAL SCREWS WITH RATCHETING HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088740 ↗MalfunctionMay 1, 2026Fracture
IT WAS REPORTED THAT THE DRIVER TIP BROKE WHILE TIGHTENING SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056844 ↗MalfunctionApr 28, 2026
DURING THE PROCEDURE A PIECE OF THE SCREW BIT BROKE OFF IN THE PATIENT'S LEFT SHOULDER. MD PULLED OUT THE BROKEN PIECE. X RAY CAME TO THE ROOM WITH A C ARM TO GET X RAY. MD CONFIRMED THAT NO PIECES WERE LEFT IN THE PATIENT'S ARM UTILIZING X RAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014472 ↗MalfunctionApr 23, 2026Fracture
SALES REPRESENTATIVE REPORTED THAT THE SCREWDRIVER BIT BROKE DURING THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24968381 ↗MalfunctionMar 31, 2026Fracture
SCREWDRIVER TIP BROKE WHEN THE SURGEON WAS INSERTING THE GLENOSPHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24745396 ↗MalfunctionMar 20, 2026Fracture
SCREWDRIVER SHAFT BROKE DURING GLENOSPHERE TIGHTENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24656052 ↗MalfunctionMar 19, 2026Fracture
2 SCREWDRIVER TIPS WERE BROKEN INSERTING PERIPHERAL SCREWS ONTO THE BASEPLATE, AND UPON WASHING THE ATTACHMENT TO THE IM CUT GUIDE, IT WAS NOTICED THAT THE KNOB WAS BENT AND COULD NO LONGER BE SCREWED DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639271 ↗MalfunctionMar 19, 2026Fracture
2 SCREW DRIVER TIPS WERE BROKEN INSERTING PERIPHERAL SCREWS ONTO THE BASEPLATE, AND UPON WASHING THE ATTACHMENT TO THE IM CUT GUIDE, IT WAS NOTICED THAT THE KNOB WAS BENT AND COULD NO LONGER BE SCREWED DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638786 ↗
Other BIT, SURGICAL devices
- 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
- ACUFEX 72204043Smith & Nephew, Inc. · BIT, SURGICAL11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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