Integra® INS030Recalls & reported problems

Integra Pain Management · Integra® Hand Drill - Sterile

Data updated Oct 16, 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 10381780263890), received between Aug 21, 2024 and Aug 21, 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. 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 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.

MalfunctionAug 21, 2024Device-Device Incompatibility; Device-Device Incompatibility
A FACILITY REPORTED THAT DURING NEUROSURGERY, AT THE END OF PROCEDURE, IT WAS NOTICED THAT ONE SCREW WAS COMING OUT FROM THE "HAND DRILL: STERILE (INS030)", DESPITE A PROPER FIXATION. THE PATIENT DID NOT HAVE ANY CLINICAL CONSEQUENCES (DESPITE THE RISK OF LOSING CONTROL OF THE INSTRUMENT THAT COULD HAVE LED TO CRANIAL BLOOD LOSS). ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: DESCRIPTION: THE DRILL BIT COMES OUT OF THE HAND DRILL BECAUSE IT WAS NOT HELD PROPERLY DESPITE PROPER PLACEMENT. WHICH TYPE OF DRILL BIT WAS USED WITH INS030? DRILL BIT CONTAINED IN THE SOPHYSA KIT (PRESSIO, NOT INTEGRA PRODUCT) REFERENCE AND LOT NUMBER IF KNOWN? PSO-PB (PRESSIO® ICP MONITORING KIT, PARENCHYMAL WITH BOLT), LOT UNKNOWN. NOT INTEGRA PRODUCT. DRILL BIT DIAMETER? 2.7MM. WHICH PROCEDURE: IMPLANT OF INTRACRANIAL PRESSURE SENSOR. DID IT LEAD TO ANY INCREASE OF SURGERY TIME? ABOUT 3 MINUTES FOR A PROCEDURE WHICH USUALLY TAKES 15 MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20013563 ↗

Device details

UDI-DI	`10381780263890`
Brand	Integra®
Model	INS030
Company	Integra Pain Management
Product code	—
Class	—
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 17, 2023

Device type (GMDN): Manual cranial rotary handpiece, single-use

A manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). This is a single-use device.

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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