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 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 that during trepanation, the perforator (id 261221) did not disengage causing a dura mater tear.No clinical consequences for the patient.

Event Description

N/a.

Manufacturer Narrative

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 the unaided eye performed.The unit was lightly soiled on the visible surface but was heavily soiled on the inside of the unit once the sleeve was removed.Unit also had a worn label.Spring test attempted, the inner / outer drill were fused and unit initially failed the spring test due to the very limited compression using downward force.A test hole was conducted to try and free the inner / outer but was unsuccessful.At this point the unit had the sleeve removed showing significant organic matter caked inside - this is likely the cause of the frozen inner / outer.The unit was then soaked in 70% ipa for 3 hours, and the organic material was removed.Once cleaned the unit was re-sleeved and passed the spring test as designed.Functional test performed once unit was re-sleeved and passed by successfully drilling 5 holes with no issues.In conclusion although the unit initially failed this was due to the "dried" organic matter freezing up the inner / out drill.The organic matter would not have frozen the drill at the time of surgery.Unit passed all tests post-cleaning therefore, the complaint could not be verified.Root cause remains undetermined.Product was received for analysis and the analyst could not confirm the complaint condition.

• 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: 16765812
• MDR Text Key: 313558237
• Report Number: 3014334038-2023-00050
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

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: 6899306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2022
• 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