LC-DCP 323.35Recalls & reported problems
Synthes GmbH · 3.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982190802), received between Aug 29, 2019 and Sep 15, 2022 — classified as 3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: NEW DRILL GUIDE WAS PURCHASED TO REPLACE ONCE WHICH HAD HAD A SMALL SPRING FALL OUT. APPARENTLY WHEN IT WAS WASHED FOR THE FIRST TIME THE SAME SMALL SPRING FELL OUT IN THE WASHER. EVENT OCCURRED IN STERILE PROCESSING ON AN UNKNOWN DATE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR 3.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15432532 ↗MalfunctionSep 15, 2020Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING CLEANING AND REPROCESSING, THE REPROCESSING STAFF IDENTIFIED THAT THE BALL-BEARING WAS BROKEN AND THE INSTRUMENT NO LONGER FUNCTIONED ADEQUATELY. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10535058 ↗MalfunctionAug 29, 2019Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING CLEANING ON AN UNKNOWN DATE, THE SPRING-LOADED BALL FELL OFF THE DRILL GUIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 3.5 MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8946629 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.