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

Catalog Number	261221
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A physician reported disengagement failure of a codman perforator while making the second burr hole at the tent (id (b)(6)).Dural damage and brain contusion were observed and hemostasis was performed.The event led to more than 30 minutes surgical delay.The patient¿s condition is stable.The manufacturer of the drill used with the perforator was anspach e-max.According to information provided, it is unknown if the drill was electric or pneumatic.It is also unknown if the perforator clicked in place in the drill and if the recommended spring tests were performed between each burr hole.Customer also informed that is unknown if the angle of approach was perpendicular as the ifu states.It is unknown if the perpendicular approach maintained through the drilling process or if there was any rocking motion included, and unknown if there was constant downward pressure.
Additional Manufacturer Narrative
The codman perforator (id 261221) was returned for evaluation.Failure analysis - the perforator unit was inspected using the unaided eye.The unit was lightly soiled with organic material and had a completely worn eo label.The weld on the blue sleeve looked shallow.The unit was found to perform as intended and fulfilled the acceptance criteria.The unit did feel slightly ¿dull¿ when drilling, but disengagement failure could not be replicated.Root cause analysis ¿ the root cause is undetermined and was unable to be confirmed in the complaint evaluation.However, a potential cause of failure includes under misuse.

• Brand Name: CODMAN DISPOS PERFORATOR
• Common Device Name: 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: 17967955
• Report Number: 3014334038-2023-00172
• Device Sequence Number: 12460105
• Product Code: HBF
• UDI-Device Identifier: 10886704005100
• UDI-Public: 10886704005100
• Combination Product (Y/N): N
• PMA/510(K) Number: K791101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown