MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRANIOTOMY KIT; DISPOSABLE PERFORATORS

Model Number 261230

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 11/24/2022

Event Type  Injury  

Event Description

A facility reported a perforator (id 261230) failed to disengage causing dural tear, cortical exposure, with direct neurological risk.Medical staff used duraplasty device (patch for dura matter as tachoseal).The event led to 20 minutes surgical delay and no patient consequences were reported.

Manufacturer Narrative

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

Manufacturer Narrative

The perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - a visual inspection utilizing unaided eye performed.Unit was soiled and had a worn eo label.Spring test attempted: unit passed and functioned as designed.Functional test performed: unit successfully drilled 5 holes and was found to function as intended.Therefore, the complaint condition could not be confirmed.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.

Event Description

N/a.

• Brand Name: CRANIOTOMY KIT
• 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: 16022588
• MDR Text Key: 306075725
• Report Number: 3014334038-2022-00285
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513629
• UDI-Public: 10381780513629
• Combination Product (y/n): N
• PMA/PMN Number: K073336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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 Model Number: 261230
• Device Catalogue Number: 261230
• Device Lot Number: 6282116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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