NA 03.122.040Recalls & reported problems
Synthes GmbH · 4.3MM VARIABLE ANGLE DOUBLE DRILL GUIDE WITH CONE · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982074829), received between Nov 14, 2022 and Aug 19, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility3
- Break2
- Corroded1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Break; Corroded; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328043 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24833506 ↗MalfunctionDec 22, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE 4.3 VA CONE DRILL GUIDE (03.122.040) WAS WORN OUT AND WOULD NOT INTERFACE WITH THE PLATE PROPERLY. SURGERY WAS COMPLETED SUCCESSFULLY AND WITHOUT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864729 ↗MalfunctionNov 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE, THE VA CONE GUIDE DID NOT SIT PROPERLY ON THE PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619553 ↗MalfunctionNov 14, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT WAS FOUND IN SPD WITH THE DRILL BIT STUCK IN IT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.3MM VARIABLE ANGLE DOUBLE DRILL GUIDE WITH CONE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15787482 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.