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

Model Number	261230
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a perforator did not disengage causing a tear in the dura matter.Suture was necessary to stop the bleeding of the superior sagittal sinus.The perforator was used in a surgery for meningioma.
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.
Additional 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 perforator unit was inspected using the unaided eye.No anomalies were observed.Functional spring test and functional test were performed; no anomalies observed.Based off the failure analysis the complaint could not be confirmed.Root cause - he root cause is undetermined and was unable to be confirmed in the complaint evaluation.A review of the device history record and trending were performed as part of the evaluation.Product was received for analysis and the investigation could not confirm the complaint.Potential causes of failure include: user misuse.

• Brand Name: CRANIOTOMY KIT
• 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: 15148291
• Report Number: 3014334038-2022-00174
• Device Sequence Number: 5589254
• Product Code: HBF
• UDI-Device Identifier: 10381780513629
• UDI-Public: 10381780513629
• Combination Product (Y/N): N
• PMA/510(K) Number: K073336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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 Model Number: 261230
• Device Catalogue Number: 261230
• Device Lot Number: 6300030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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