MAUDE Adverse Event Report: ACRA CUT, INC. ACRA-CUT DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11 MM

Model Number 210-221

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2017

Event Type  malfunction  

Event Description

During a frontotemporoparietal craniectomy, the plastic shaft of the cranial perforator broke as a burr hole was being made.The patient did not suffer any injury or adverse outcome.The broken parts of the perforator were immediately retrieved.Device sent to (b)(4).

• Brand Name: ACRA-CUT DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11 MM
• Type of Device: PERFORATOR
• Manufacturer (Section D): ACRA CUT, INC. ; 989 main st.; acton MA 01720
• MDR Report Key: 6525681
• MDR Text Key: 73972729
• Report Number: MW5069363
• Device Sequence Number: 1
• Product Code: HBF
• 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: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210-221
• Device Catalogue Number: 210-221
• Device Lot Number: 9250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 80