NA 03.127.005Recalls & reported problems
Synthes GmbH · TROCAR FOR 2.8MM VA SPHERICAL DRILL GUIDE-LONG · Class 1
Data updated Oct 16, 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 10886982075055), received between Oct 29, 2018 and Oct 29, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Deformation2
- Material Twisted/Bent1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS DISCOVERED THAT THE TROCAR FOR 2.8MM SPHERICAL DRILL GUIDE WAS BENT. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TROCAR FOR 2.8MM VA SPHERICAL DRILL GUIDE-LONG THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10756838 ↗MalfunctionJun 26, 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 FOR VARIABLE ANGLE (VA) SPHERICAL DRILL GUIDE WAS BENT AND DAMAGED. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TROCAR FOR 2.8MM VA SPHERICAL DRILL GUIDE-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10199672 ↗MalfunctionOct 29, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2018, A TROCAR FOR 2.8MM LONG VARIABLE ANGLE DRILL GUIDE WAS FOUND TO BE BENT. THIS WAS DETERMINED DURING A ROUTINE INSPECTION OF THE SET. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A TROCAR FOR 2.8MM VA SPHERICAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8015680 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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