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NA 03.605.009Recalls & reported problems

Synthes GmbH · MIDLINE MARKER 8MM WIDTH 250MM · 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 10705034712413), received between Jun 25, 2021 and Jun 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 Integrity Problem1

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.

  • MalfunctionJun 25, 2021Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, A MIDLINE MARKER CORNER OF THE CHISEL BROKE OFF DURING SURGERY. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. NO PATIENT HARM. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) MIDLINE MARKER 8MM WIDTH 250MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12068572 ↗

Other OSTEOTOME devices

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