MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 04/05/2024

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a perforator (id 261221) plunged (the clutch did not engage).During the drilling phase of surgery it became apparent that it was taking longer than anticipated to drill through the skull, while drilling the bone matter become red and very dark blood like ¿ the surgeon continued to drill checking the drill integrity at this step.As the drilling continued all of a sudden the chuck engaged and stopped the perforator rotating ¿ the drill was then removed and it become apparent that the drill had went through the dura and into the brain damaging some of the brain.Bleeding was stopped with electro surgery ¿ bipolar forceps.The wound was irrigated and cleaned ¿ bleeding vessels cauterized and bleeding bone segments had bone wax applied to them providing hemostasis.This event added around ten extra minuets to the surgical time.At this stage medical staff moved to the router phase to create a bone flap to gain full access to the patient¿s brain.An electric stryker drill was used with the perforator.The perforator clicked in place with the drill and the recommended spring tests were performed between each burr hole.It was confirmed the angle of approach was perpendicular as stated in the ifu and that the surgeon kept constant downward pressure during the whole drilling phase ensuring that it was engaged correctly.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 19192874
• MDR Text Key: 341167932
• Report Number: 3014334038-2024-00088
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: 7263634
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/26/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1