NA 397.21Recalls & reported problems
Synthes GmbH · 2.4MM TROCAR WITH HANDLE & OBTURATOR · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587041186), received between Jul 2, 2019 and Jan 4, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Break1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE OBTURATOR INSERT WAS BENT AND WOULD NOT FIT IN THE HANDLE/DRILL GUIDE. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE WAS NOTED POSTOPERATIVELY. THIS REPORT INVOLVES ONE 2.4MM TROCAR WITH HANDLE & OBTURATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18442767 ↗MalfunctionDec 5, 2019Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SERVICE AND REPAIR WAS NOTIFIED OF A BROKEN SYNTHES TRANSBUCCAL GUIDE. NO OTHER DETAILS HAVE BEEN PROVIDED. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) 2.4MM TROCAR WITH HANDLE & OBTURATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 9416204 ↗MalfunctionJul 2, 2019Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE WOODEN HANDLE WITH QUICK COUPLING BROKE. THE DRILL GUIDE CAUSES THE TROCAR TO STICK AND EVENTUALLY GETS STUCK. IT IS UNKNOWN IF THERE WAS A PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.4MM TROCAR WITH HANDLE & OBTURATOR. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8754541 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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