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NA 399.48.96Recalls & reported problems

Synthes GmbH · PERIOSTEAL ELEVATOR 3MM CURVED BLADE - STRAIGHT EDGE · 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 10886982202840), received between Aug 30, 2017 and Aug 30, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • 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.

  • MalfunctionAug 30, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT SCREW DRIVER WOODEN HANDLES FROM A MODULAR HAND SYSTEM ARE BLEEDING AND LEAVING STAINS ON THE LIDS AND CAUSING A CONCERN. THERE IS NO PATIENT INVOLVED AS THIS IS HAPPENING IN STERILE PROCESSING DEPARTMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE. (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 6832117 ↗

Other ELEVATOR devices

All ELEVATOR devices →

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