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

Model Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 11/14/2022

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) did not stop when it was in contact with dura mater causing a defect in dural sealing, possible dural leakage and risk of neurological deficit.The event required medical intervention to seal the dura.

Event Description

N/a.

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 - visual inspection utilizing unaided eye performed, unit was soiled, and had a destroyed eo label.Organic material between the inner / outer drill.Spring test attempted; unit rotated fine but the spring would not compress from organic material present.Unit was freed by drilling 5 test holes, then passed the spring test and functioned as designed.Functional test performed.Five test holes were drilled to free the inner / outer and allow the spring to compress.Once freed the unit successfully drilled 5 additional holes and was found to function as intended.Complaint could not be verified.Unit was found to meet all acceptance criteria.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.

• 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: 15931882
• MDR Text Key: 304972278
• Report Number: 3014334038-2022-00275
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• 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: 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: 261221
• Device Catalogue Number: 261221
• Device Lot Number: J83A41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• 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