VariAx 45-80100Recalls & reported problems
Stryker GmbH · K-WIRE, FULLY THREADED · Class 1 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154628902), received between Nov 29, 2017 and Jan 3, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment Of Device Component1
- Difficult to Remove1
- No Apparent Adverse Event1
Patient problems
- No Code Available2
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT MIDFOOT. METALLOSIS WAS OBSERVED DURING REMOVAL.
Patient problems: Injury; No Code Available
MAUDE report 9549221 ↗InjuryNov 29, 2017Break; Detachment Of Device Component; Difficult to Remove
AS REPORTED: "K-WIRE WAS DRIVEN IN TO BONE WITH STRYKER CD8 CORDLESS DRIVER AND WIRE COLLET (FACILITY OWNED). THE K-WIRE BROKE OFF IN THE FIBULA. CASE WAS AN ORIF RIGHT FIBULA. THE K-WIRE WAS BARELY PROTRUDING POSTERIOR AND MEDIAL IN THE FIBULA. THE CAPITAL FRAGMENT OF THE WIRE WAS REMOVED BUT BROKEN TIP WAS STUCK IN THE BONE AND UNABLE TO BE REMOVED EASILY. TIP PROTRUDING WAS TOO SHORT TO GRIP WITH THE WIRE COLLET AND FURTHER COMPLICATED BY ITS POSITION BEING DIFFICULT TO ACCESS. SURGEON ATTEMPTED TO CUT THE TIP TO NO AVAIL. SURGEON ATTEMPTED TO BEND THE WIRE UP AND INTO THE BONE TO PREVENT SOFT TISSUE IRRITATION TO NO AVAIL. WIRE WAS ULTIMATELY REMOVED BY MAKING MULTIPLE HOLES IN THE BONE WITH A K-WIRE ADJACENT TO THE WIRE TO LOOSEN AND FREE IT TO THE POINT WHERE IT COULD BE GRIPPED AND PULLED FREE." DELAY IN SURGERY AND MULTIPLE HOLES MADE IN THE BONE WITH ANOTHER K-WIRE. SURGICAL DELAY OF 30-40 MINUTES.
Patient problems: No Code Available
MAUDE report 7069140 ↗
Other Guide, Surgical, Instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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.
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