Virage® 07.01764.002Recalls & reported problems
Zimmer Biomet Inc · Class 1
All models of Virage (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887868289095), received between Aug 11, 2022 and May 28, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO VIRAGE DRIVER TIPS FRACTURED WHEN ATTEMPTING TO REMOVE A SCREW AT T-2 INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED WITH A THIRD DRIVER, RESULTING IN A 20 MINUTE DELAY BUT NO PATIENT HARM. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22100068 ↗MalfunctionMay 28, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO VIRAGE DRIVER TIPS FRACTURED WHEN ATTEMPTING TO REMOVE A SCREW AT T-2 INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED WITH A THIRD DRIVER, RESULTING IN A 20 MINUTE DELAY BUT NO PATIENT HARM. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22100058 ↗MalfunctionOct 15, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, A VIRAGE SCREWDRIVER FRACTURED AT THE TIP AND A 5.5MM DIAMETER VIRAGE SCREW BROKE APART AT THE TULIP HEAD. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL SCREW DRIVERS AND SCREWS IN THEIR SET. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 10-15 MINUTE DELAY TO GRAB NEW SCREW DRIVERS AND SCREW.THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20452810 ↗MalfunctionMay 22, 2023Fracture; Fracture
IT WAS REPORTED THE TIP OF THE VIRAGE POLY-AXIAL SCREWDRIVER BROKE WHILE POSITIONING DURING A CERVICAL FIXATION AT C4. THE BROKEN PIECE WAS RETRIEVED WITH A PAIR OF SURGICAL TWEEZERS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRIVER. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973857 ↗MalfunctionAug 11, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE TIP OF A SCREW DRIVER FRACTURED. ALL PARTS WERE RETRIEVED AND THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15214668 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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