NA 319.52Recalls & reported problems

Synthes GmbH · DEPTH GAUGE FOR 1.5MM & 2.0MM SCREWS, LONG · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587039022), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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

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

Most reported problems

Device problems

Device-Device Incompatibility1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 19, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE THE TIP OF THE DEPTH GAUGE DID NOT ENGAGE WITH THE BONE PROPERLY. SURGERY WAS DELAYED 2 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT DEPTH GAUGE THIS REPORT IS FOR ONE DEPTH GAUGE FOR 1.5 & 2.0 SCREWS, LONG FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18928772 ↗

Device details

UDI-DI	`10887587039022`
Brand	NA
Model	319.52
Catalog no.	31952
Company	Synthes GmbH
Product code	HTJ · GAUGE, DEPTH
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	Apr 25, 2022

Device type (GMDN): Surgical depth gauge, reusable

A surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Other GAUGE, DEPTH devices

NA 319.006
Synthes GmbH · GAUGE, DEPTH
899 reports
NA 03.133.080
Synthes GmbH · GAUGE, DEPTH
174 reports
NA 03.010.072
Synthes GmbH · GAUGE, DEPTH
133 reports
MULTILOC 03.019.017
Synthes GmbH · GAUGE, DEPTH
119 reports
NA 319.01
Synthes GmbH · GAUGE, DEPTH
113 reports
NA 319.004
Synthes GmbH · GAUGE, DEPTH
82 reports
QUICKSET 2274-60-000
Depuy (Ireland) · GAUGE, DEPTH
68 reports
NA 319.09
Synthes GmbH · GAUGE, DEPTH
65 reports

All GAUGE, DEPTH 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page