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NA 357.387Recalls & reported problems

Synthes GmbH · 4.0MM TROCAR 176MM · 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 10886982196149), received between Jun 18, 2019 and Jun 18, 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 18, 2019Material Deformation; Material Deformation

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCAR WAS INDICATED AS WORN AND DAMAGED BY THE MEDICAL DEVICE REPROCESSING (MDR) STAFF. THE TROCAR WAS SLIGHTLY BENT AND DOES NOT FIT PROPERLY INTO AN UNKNOWN SLEEVE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES: SLEEVE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.0MM TROCAR 176MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8707571 ↗

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