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 Speech Disorder (4415)

Event Type  Injury  

Event Description

A facility reported a perforator (id (b)(6)) was used in a craniotomy for resection of left temporal gbm 14mm.As is standard to place a burrhole prior to craniotomy clutch mechanism appears to have failed, resulting in the drill bit plunging into the patient's brain.A second burrhole was attempted using the same drill bit, but it was noticed that the same error would have occurred so this was abandoned.The second burrhole was completed successfully with a replacement product available.The event led to a not significant surgical delay.As a result, the patient has speech impairment.The manufacturer of the drill used with the perforator was an electronic medtronic drill.The perforator did not click in place a few seconds after starting a second burr hole and did not pass the spring test, and so it was abandoned and replaced with a new drill bit.

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

N/a.

Manufacturer Narrative

Additional information received: "the initial speech impairment was severe.Although there has been some significant improvement, there will be permanent impairment".

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 - the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.Root cause is undetermined and was unable to be confirmed in the complaint evaluation.Potential causes of failure include: user misuse.

Manufacturer Narrative

Investigation update: root cause: per the medical assessment performed, the harm that occurred to the patient cannot be directly related to the failure of the product without additional information which has not been provided.The patient's condition suggests that speech impairments are a possibility and therefore it may not be that the speech impairment is related to the product failure.

Event Description

N/a.

• 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: 17435196
• MDR Text Key: 320164316
• Report Number: 3014334038-2023-00123
• 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,Followup,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• 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: 6973642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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