QWIX® 119104NDRecalls & reported problems
Newdeal · The hexagonal cannulated graduated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used on a quick coupling handle to implant and explant the 4.3mm fixation screws. · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780052050), received between Jul 29, 2021 and Jun 8, 2022 — classified as 1 injury, 2 malfunctions.
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.
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT, DURING SURGERY, THE DIAM 4.3MM SCREWDRIVER AXIS BROKE INSIDE OF THE PATIENT. PIECES WERE SUCCESSFULLY REMOVED USING FORCEPS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAYS WERE REPORTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14633513 ↗MalfunctionMay 17, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING SCARF SURGERY, ONE (1) DIAM 4.3MM SCREWDRIVER AXIS BROKE OFF WHILE BEING HANDLED OUTSIDE THE PATIENT. A SURGICAL DELAY OF LESS THAN 30 MIN WAS REPORTED TO OCCUR, AND THE PROCEDURE WAS RESUMED WITH A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT WAS NOT HARM BEYOND THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14416241 ↗MalfunctionJul 29, 2021Break; Break
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page