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NA 399.197Recalls & reported problems

Synthes GmbH · HOHMANN RETRACTOR 8MM NARROW TIP 215MM · 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 10886982202543), received between Oct 22, 2019 and Oct 22, 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

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionOct 22, 2019Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE HOHMANN RETRACTOR WAS OBSERVED TO BE BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) HOHMANN RETRACTOR 8MM NARROW TIP 215MM. THIS IS 1 FO 1 FOR REPORT (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9219717 ↗

Other RETRACTOR devices

All RETRACTOR devices →

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