MAUDE Adverse Event Report: ACRA CUT, INC. ACRA CUT CRANIAL PERFORATORS; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Catalog Number 200-271-DGR-O

Device Problem No Device Output (1435)

Patient Problem No Information (3190)

Event Date 08/25/2016

Event Type  malfunction  

Event Description

Perforator did not read pressure change from skull to dura and continued to drive into dura, and potentially brain (at this point, it is unknown extent of harm).After speaking to stryker rep, (b)(4), he stated the acra cut is the mechanism that discontinues the driver.

• Brand Name: ACRA CUT CRANIAL PERFORATORS
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): ACRA CUT, INC.; 989 main street; acton MA 01720
• MDR Report Key: 5966060
• MDR Text Key: 55231160
• Report Number: 5966060
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2016,09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 200-271-DGR-O
• Device Lot Number: 9163
• Other Device ID Number: EXPIRATION: 05-2026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2016
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR