VARIAX 703882Recalls & reported problems
Stryker GmbH · Drill Guide, Comp,Polyax 2.6mm Drill, T10 · Class 1
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327069921), received between Apr 28, 2023 and Jul 24, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Degraded” (1 report).
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
- Degraded1
- Material Discolored1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2024Material Discolored; Material Discolored
COLOR MARKING ON DRILL GUIDE ARE COMPLETELY DISAPPEARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19816254 ↗MalfunctionApr 28, 2023Degraded; Degraded
AS REPORTED: "ORIF FOR LEFT CLAVICLE WAS PERFORMED. WHEN AN OPERATING ROOM STAFF CHECKED THE USED INSTRUMENTS AFTER POSTOPERATIVE CLEANING, IT WAS FOUND THAT COLOR PAINT (GREEN OR ORANGE) OF THE TWO DRILL GUIDES (CAT#703882, 703883) HAD PEELED OFF. IT WAS UNKNOWN WHEN THE PAINTS PEELED OFF."
Patient problems: Insufficient Information
MAUDE report 16837860 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page