MINI KN1116Recalls & reported problems
Stryker GmbH · Non-Threaded Kwire · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327363197), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (1 report).
1 other recall cover devices cleared under the same FDA submission (K120493); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2022Mechanical Jam; Mechanical Jam
AS REPORTED: "INSTRATEK MINI 3.0 SCREW WAS INSERTED PER THE OP-TECH DURING AN MPJ FUSION AS AN INDEPENDENT LAG SCREW AND THE SCREW BROKE IN HALF." ADDITIONAL INFORMATION RECEIVED - 12/16/2021: THE SURGICAL DELAY WAS APPROXIMATELY 30-40 MINUTES AS (B)(6) WANTED TO REMOVE BOTH PORTIONS OF THE BROKEN SCREW. ADVERSE CONSEQUENCES HAVE NOT BEEN BROUGHT TO MY ATTENTION. THE PATIENT HAD HARD BONE. PRE DRILLING WAS PERFORMED BUT NOT ON THE FAR CORTEX. (B)(6) USED A SHANNON BURR AROUND THE THREADS THAT WERE PROTRUDING FROM THE 1ST MET HEAD IN ORDER TO GIVE HIM ROOM TO GRAB ONTO THE SCREW AND PULL IT OUT. IRRIGATION WAS PERFORMED FOLLOWING THIS AND DBM WAS INSERTED TO FILL THE VOID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13873209 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K120493. One submission often covers many models, so check the product and lot details in each record.
- Z-2679-2014 · Apr 25, 2013 · TerminatedMini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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