NA 323.035Recalls & reported problems

Synthes GmbH · 1.8MM THREADED DRILL GUIDE SHORT · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20886982190618), received between Dec 20, 2023 and Dec 20, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device-Device Incompatibility4
Material Deformation4

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 20, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION HAVE BEEN DAMAGED WITH USE. THE DRILL SLEEVES WILL NOT ACCEPT DRILL BITS, THEY ARE POSSIBLY BENT. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 1.8MM THREADED DRILL GUIDE SHORT. THIS IS REPORT 5 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363575 ↗
MalfunctionDec 20, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION HAVE BEEN DAMAGED WITH USE. THE DRILL SLEEVES WILL NOT ACCEPT DRILL BITS, THEY ARE POSSIBLY BENT. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 1.8MM THREADED DRILL GUIDE SHORT. THIS IS REPORT 6 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363574 ↗
MalfunctionDec 20, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION HAVE BEEN DAMAGED WITH USE. THE DRILL SLEEVES WILL NOT ACCEPT DRILL BITS, THEY ARE POSSIBLY BENT. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 1.8MM THREADED DRILL GUIDE SHORT. THIS IS REPORT 4 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363572 ↗
MalfunctionDec 20, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 21-NOVEMBER-2023, THE INSTRUMENTS IN QUESTION HAVE BEEN DAMAGED WITH USE. THE DRILL SLEEVES WILL NOT ACCEPT DRILL BITS, THEY ARE POSSIBLY BENT. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 1.8MM THREADED DRILL GUIDE SHORT. THIS IS REPORT 3 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363569 ↗

Device details

UDI-DI	`20886982190618`
Brand	NA
Model	323.035
Catalog no.	323035
Company	Synthes GmbH
Product code	FZX · Guide, surgical, instrument
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 2, 2022

Device type (GMDN): Surgical drill guide, reusable

A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Other Guide, surgical, instrument devices

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NA 03.010.404
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All Guide, surgical, instrument devices →

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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