LCP 03.114.001Recalls & reported problems
Synthes GmbH · 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES · Class 1
All models of LCP (367)
Data updated Oct 18, 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 10886982072986), received between May 26, 2017 and Mar 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
- Failure to Align1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT OPEN REDUCTION AND FIXATION OF A PHALANX IN A HAND FRACTURE ON (B)(6) 2025. THE GUIDE DID NOT THREAD EASILY INTO THE BLOCKED HOLES. IT HAD BEEN DECIDED TO USE A 1.5 PLATE. THE DOCTOR WAS INFORMED IN ADVANCE THAT THE LCP EQUIPMENT HAD BEEN SENT TO HIM. THE PLATE WAS TRIMMED AND IMPLANTED. THE LOCKING GUIDE DID NOT THREAD INTO THE HEAD HOLES, SO THE DOCTOR DECIDED TO DRILL FREEHAND. THE SCREWS DID NOT LOCK, CAUSING INSTABILITY OF THE FRACTURE. THE DOCTOR DECIDED TO REMOVE THE HARDWARE AND LEAVE PINS FROM THE INSTITUTION. THE SPECIALIST PREFERABLY REQUIRED HAND-HELD EQUIPMENT.
Patient problems: Insufficient Information
MAUDE report 21587513 ↗MalfunctionMay 26, 2017Failure to Align; Failure to Align
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS FOUND THE DRILL GUIDE COULD NOT BE INSERTED INTO THE PLATE HOLE. A SECOND DRILL GUIDE WAS TRIED AND ALSO COULD NOT BE INSERTED INTO THE PLATE HOLE EITHER. THE SURGERY WAS EXTENDED FOR TWENTY (20) MINUTES. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME. THIS REPORT IS FOR A VETERINARY CASE; THERE IS NO HUMAN PATIENT INVOLVEMENT. CONCOMITANT DEVICE: PLATE (QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6593903 ↗
Other Guide, surgical, instrument devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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