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NA 357.039Recalls & reported problems

Synthes GmbH · 2.8MM GUIDE WIRE 350MM · Class 2

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 10886982195692), received between Jun 19, 2019 and Jun 19, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionJun 19, 2019Material Deformation; Material Deformation

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GUIDE WIRE WAS BENT DURING SHIPPING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 2.8MM GUIDE WIRE 350MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8711764 ↗

Other PIN, FIXATION, THREADED devices

All PIN, FIXATION, THREADED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.