LCP 03.108.009Recalls & reported problems
Synthes GmbH · 2.8MM THREADED DRILL GUIDE FOR 3.5MM PEDIATRIC LCP HIP PL · Class 1
All models of LCP (367)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982071590), received between May 21, 2024 and Nov 24, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Device-Device Incompatibility3
- Material Deformation2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025, THE WRENCHES IN THE PEDIATRIC HIP SET WOULD NOT GRIP THE LOCKING TOWERS TO INSERT INTO THE PLATES. APPEARED TO BE STRIPPED/ROUNDED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23637411 ↗MalfunctionNov 24, 2025Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025, THE WRENCHES IN THE PEDIATRIC HIP SET WOULD NOT GRIP THE LOCKING TOWERS TO INSERT INTO THE PLATES. APPEARED TO BE STRIPPED/ROUNDED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23637395 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THAT THE THREADS ON DRILL GUIDE BROKE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22024862 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THAT THE THREADS ON DRILL GUIDE BROKE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22024668 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THAT THE THREADS ON DRILL GUIDE BROKE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22023752 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THAT THE THREADS ON DRILL GUIDE BROKE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22023751 ↗MalfunctionMay 21, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE DRILL GUIDE WAS NOT THREADING INTO THE PEDIATRIC HIP PLATE AFTER MULTIPLE ATTEMPTS. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE FOR 3.5MM PEDIATRIC LCP HIP PL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19360741 ↗
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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