MAUDE Adverse Event Report: ACRA-CUT, INC. ACRA-CUT DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number #200-271-DGR-O

Device Problems Premature Activation (1484); Fail-Safe Problem (2936)

Patient Problem Laceration(s) (1946)

Event Date 03/04/2022

Event Type  malfunction  

Event Description

During a right parietal craniotomy surgical procedure, a acra-cut cranial perforator was utilized and didn't stop as it is designed to.The perforator stopped prior to inner cortical bone.The perforator went through inner cortical bone.The perforator stopped prematurely.This resulted in significant dural tears because of the failed safety mechanism.The drill speed was 75,000 with perforator chuck.Fda safety report id # (b)(4).

• Brand Name: ACRA-CUT DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): ACRA-CUT, INC.; acton MA 01720
• MDR Report Key: 13966190
• MDR Text Key: 288382279
• Report Number: MW5108644
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: #200-271-DGR-O
• Device Lot Number: 10138
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White