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

Catalog Number	261230
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a perforator (id: 261230) failed to disengage causing a dural injury requiring to be repaired with coagulation of the vessel on the surface.The procedure was completed with a replacement product available.
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 was 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, the unit had a worn eo label, but showed no other anomalies.Spring test attempted, unit passed the spring test and functioned as designed.Functional test performed, unit successfully drilled 5 holes with no issues and functioned as designed.Complaint could not be verified.Unit passed all functional tests therefore, the complaint condition could not be confirmed.Root cause - product was received for analysis and the investigation could not confirm the complaint condition.Root cause remains undetermined.Possible root cause per the failure analyst ¿drill allows to be set incorrectly¿ or ¿user misuse¿.
Event or Problem Description
N/a.

• 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: 17100888
• Report Number: 3014334038-2023-00094
• Device Sequence Number: 16618100
• 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): 08/02/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 261230
• Device Lot Number: 6508227
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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