NA 312.155Recalls & reported problems
Synthes GmbH · 1.5MM DRILL GUIDE · 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 10887587036489), received between Aug 24, 2018 and Mar 21, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Material Deformation2
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2023Material Deformation; Material Deformation
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT UPON INSPECTION OF LOANER SET (CR# 51259, L01.503.504.1 MATRIX MIDFACE SYSTEM), CUSTOMER REPORTED INSTRUMENT DRILL GUIDE WAS BENT/DAMAGED. UNKNOWN IF THE EVENT OCCUR DURING STERILE PROCESSING OR DURING FIELD INSPECTION. THIS REPORT IS FOR ONE (1) 1.5MM DRILL GUIDE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16586402 ↗MalfunctionDec 11, 2019Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE DRILL GUIDE WAS BROKEN INTO TWO (2) PIECES. IT WAS ISSUED AND FOUND DURING INSPECTION AT LOANERS DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 1.5MM DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9453217 ↗MalfunctionAug 24, 2018Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DURING AN INSPECTION OF SETS, THE LOANERS DEPARTMENT FOUND THAT THE ONE (1) DRILL GUIDE AND TWO (2) MATRIXMIDFACE DRILL BITS WERE BROKEN, BENT AND NON-REPAIRABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7813355 ↗
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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