NA 03.427.060Recalls & reported problems

Synthes GmbH · 2.7 VOLT(TM) DEPTH GAUGE 0 TO 60MM · Class 1

Data updated Oct 18, 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 10886982336514), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Deformation1

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.

MalfunctionApr 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE PRODUCT WAS DAMAGED. DEPTH GAUGE ARRIVED BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893101 ↗

Device details

UDI-DI	`10886982336514`
Brand	NA
Model	03.427.060
Catalog no.	03427060
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	Oct 17, 2024

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 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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