NA 386.900Recalls & reported problems
Synthes GmbH · ARTICULATING PLATE INTRODUCER WITH PLATE HOLDING TIP · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587040394), received between Aug 29, 2022 and Dec 4, 2023 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED A SUBCONDYLAR RAMUS FIXATION SET WAS SENT TO CUSTOMER HAS A BROKEN ADJUSTABLE PLATE INTRODUCER 386.900 WHICH MEANT THE SURGEON COULD NOT USE IT. THE BACK OF THE TIP SEEMS TO BE MISSING A PIECE AND SO THE PLATE CANNOT BE LOADED ONTO THE PLATE HOLDER. THE MATRIX MANDIBLE COMPACT TRAUMA SET ON THE SAME BOOKING ALSO HAD INCORRECTLY LOADED SCREWS WITH LOCKING SCREWS IN THE NON LOCKING COLUMNS AND A 04.503.438 IN THE 04.503.436 COLUMN THEREFORE BECOMING UNUSABLE. THE EVENT WAS DISCOVERED DURING INTERNAL SERVICE ACTIVITIES AND THERE WAS NO KNOWN PATIENT INVOLVEMENT. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THIS REPORT IS FOR PL-HOLDER ADJUST CPL FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18258782 ↗MalfunctionAug 29, 2022Break; Break
IT WAS REPORTED THAT DURING ROUTINE INSPECTION, THE PLATE CUTTER AND TIP FOR PLATE HOLDER BOTH FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ARTICULATING PLATE INTRODUCER WITH PLATE HOLDING TIP THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15316100 ↗
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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