VARIAX 703880Recalls & reported problems
Stryker GmbH · Screwdriver Blade T10 AO, Self Retaining · Class 1
Data updated Oct 13, 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 07613327069907), received between Jun 29, 2020 and Mar 26, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Break3
- Use of Device Problem1
Patient problems
- Insufficient Information2
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025Break; Fracture; Break; Fracture
THE SCREWDRIVER TIP BROKE OFF WHILE REMOVING THE SCREW.
Patient problems: Insufficient Information
MAUDE report 21698906 ↗MalfunctionDec 3, 2024Break; Fracture; Break; Fracture
AS REPORTED: "IT WOULD APPEAR THAT THE VARIAX SCREW ADAPTER PART NO. 703-880 HAS BEEN ACCIDENTALLY DISCARDED BECAUSE IT WAS BROKEN."
Patient problems: Insufficient Information
MAUDE report 20833478 ↗MalfunctionJul 10, 2024Break; Fracture; Break; Fracture
THE TIP OF THE 703880 SCREWDRIVER WAS BROKEN WHILE TIGHTENING THE SCREW DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19709565 ↗MalfunctionMar 8, 2022Use of Device Problem; Use of Device Problem
AS REPORTED: "DURING VARIAX EXTRACTION, ONE SCREW WAS UNABLE TO BE REMOVED. THE SURGEON BROKE THE SCREW HEAD AND TRIED TO REMOVE THE SCREW SHAFT WITH A CROWN REAMER, BUT THE SCREW WAS TWISTED OFF IN THE PROCESS, SO SHE CLOSED THE WOUND LEAVING ABOUT 2/3 OF THE SCREW SHAFT IN THE PATIENT'S BONE. THE PROCEDURE WAS DELAYED BY 30 MIN."
Patient problems: Foreign Body In Patient
MAUDE report 13693644 ↗MalfunctionJun 29, 2020Fracture; Fracture
AS REPORTED: DURING THE OPERATION TO REMOVE THE CLAVICLE IMPLANT, THERE WAS A FEELING OF DISCOMFORT IN FITTING THE SCREW AND DRIVER. WHEN CHECKED AFTER THE OPERATION, THE TIP OF THE DRIVER WAS DAMAGED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10206531 ↗
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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.
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