LCP 03.122.035Recalls & reported problems
Synthes GmbH · INSERTION HANDLE F/LCP PROX HUMERUS PLATE/STARDRIVE · Class 1
All models of LCP (367)
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 10886982074812), received between Apr 25, 2023 and Jan 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility2
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.
MalfunctionJan 14, 2026Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2025, THE CENTERING PEG IN THE INSERTION HANDLE IS LOOSE. THIS WAS NOTICED PRE-OPERATIVELY SO ANOTHER ONE WAS USED INSTEAD AND THERE WAS NO IMPACT TO THE PATIENT OR PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067599 ↗MalfunctionApr 25, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DATE OF THE EVENT WAS (B)(6) 2023. THIS REPORT INVOLVES ONE INSERTION HANDLE F/LCP PROX HUMERUS PLATE/STARDRIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811577 ↗
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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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