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XIA PRECISION 48230230Recalls & reported problems

Stryker Corporation · K-WIRE SHARP · Class 1

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 07613327265026), received between Aug 9, 2016 and Aug 9, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

Most reported problems

Device problems

  • Difficult to Remove1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 9, 2016Difficult to Remove

    IT WAS REPORTED THAT; SURGEON WAS PASSING A PRECISION SCREW OVER A GUIDE WIRE INTO A PEDICLE - AND ONCE PLACED, THE K-WIRE WAS UNABLE TO BE REMOVED BY HAND. THE SURGEON THEN USED A LARGE NEEDLE DRIVER TO GRASP THE GUIDEWIRE, AND PULLED AND BACKED OUT THE SCREW AT THE SAME TIME TO REMOVE IT COMPLETELY. WE THEN EXAMINED THE SCREW AND FOUND THE TIP TO BE DAMAGED AND PARTIALLY FIXED TO THE WIRE. THE SCREW AND GUIDEIRE WERE REPLACED AND SURGERY CONTINUED, COMPLETED SUCCESSFULLY. THE CASE WAS DELAYED BY ABOUT 5 MINUTES WHILE WE RESOLVED THE ISSUE. THE GUIDEWIRE UNFORTUNATELY IS UNABLE TO BE RETURNED DUE TO ACCIDENTALLY BEING THROWN AWAY IN A SHARPS BIN BY A TECH ON-SITE PRIOR TO MY CATCHING IT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5858421 ↗

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Sources and updates

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