NA 312.02Recalls & reported problems
Synthes GmbH · 2.8MM TROCAR · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982187550), received between Sep 14, 2018 and Sep 21, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Most reported problems
Device problems
- Material Twisted/Bent2
- Break1
- Material Deformation1
Patient problems
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2022Break; Break
DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INTERACTION, DEFECTS WERE DISCOVERED DURING PRE-OP INSPECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM TROCAR. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15461887 ↗MalfunctionOct 28, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A TROCAR WAS BENT. THERE WAS NO KNOWN PATIENT, OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8MM TROCAR. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10748661 ↗MalfunctionApr 29, 2019Material Twisted/Bent; Material Twisted/Bent
CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8561511 ↗MalfunctionSep 14, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2018 THE TROCAR WAS RETURNED TO THE FIELD STOCKING LOCATION FOR ROUTINE INSPECTION AND WAS FOUND TO BE BENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7877792 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.