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NA 355.22Recalls & reported problems

Synthes GmbH · RAM GUIDE · Class 1

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 10886982194831), received between Jan 31, 2019 and Jan 31, 2019 — classified as 1 malfunction.

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

  • Break1
  • Material Twisted/Bent1

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.

  • MalfunctionJan 31, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) RAM GUIDES WERE FOUND TO BE DAMAGED AND NO LONGER USABLE DURING INSPECTION. THE THREADS WERE NOTED TO BE STRIPPED OFF. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RAM GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8293033 ↗

Other Guide, surgical, instrument devices

All Guide, surgical, instrument devices →

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