MAUDE Adverse Event Report: ACRA-CUT INC. MEDTRONIX DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END MINI 11/7MM R; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Lot Number 10173

Device Problem Separation Failure (2547)

Patient Problems Laceration(s) (1946); Perforation (2001)

Event Date 12/02/2021

Event Type  Injury  

Event Description

A (b)(6) male taken to the operating room on (b)(6) 2021 for an anterior cranial vault reconstruction.Pt was found to have a small dural opening right posterior frontal under the craniotomy secondary to failure of perforator drill bit to disengage the clutch.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIX DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END MINI 11/7MM R
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): ACRA-CUT INC.; acton MA 01720
• MDR Report Key: 12975693
• MDR Text Key: 282102667
• Report Number: MW5105947
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 10173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 21 MO
• Patient Sex: Male
• Patient Weight: 12 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White