LCP 03.120.011Recalls & reported problems
Synthes GmbH · PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-LT · Class 1
All models of LCP (367)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982074096), received between Jul 14, 2017 and Jul 14, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2017Break; Break
IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A POLY-TRAUMA TO THE RIGHT FEMUR BONE DUE TO A (MVA) MOTOR VEHICLE ACCIDENT. PATIENT WAS IMPLANTED WITH A ONE (1) 12MM LATERAL ENTRY FEMORAL RECONSTRUCTION EXPERT (EX) NAIL, TWO (2) 6.5MM RECONSTRUCTION SCREWS AND ONE (1) 5.0MM LOCKING SCREW TO TREAT THE PATIENT'S BROKEN MEDSHAFT FRACTURE. PATIENT WAS ALSO IMPLANTED WITH ONE (1) 4.5MM LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE, WITH A UNKNOWN QUANTITY OF VARIOUS LENGTHS OF CANNULATED LOCKING SCREWS TO ADDRESS THE PATIENTS DISTAL FEMUR FRACTURE. DURING THE PROCEDURE, WHILE THE SURGEON WAS IMPLANTING THE LATERAL ENTRY FEMORAL NAIL, WHILE HE WAS DRILLING THROUGH THE NAIL AND ROTATING THE INSERTION HANDLE, THE ALIGNMENT METAL TAB TO THE INSERTION HANDLE BROKE OFF. ADDITIONAL IMAGES WERE TAKEN TO LOCATE THIS 2MM BY 3MM IN SIZE FRAGMENT, BUT IT COULD NOT BE LOCATED. SURGEONS CHOSE ANOTHER INSERTION HANDLE THAT WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE SURGERY. DUE TO THIS EVENT AN ADDITIONAL 15-MINUTE DELAY WAS ADDED TO OPERATING ROOM TIME. SURGEON COMPLETED THE NAIL INSERTION AND CONTINUED WITH THE DISTAL COMPRESSION PLATE AND SCREWS
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6714530 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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