MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA CRANIAL ACCESS KIT; DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Model Number INS7280

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

Ns resident was inserting an evd.The cranial access kit had a missing hex wrench.Another kit was opened.Lot# of the kit with missing hex is w2109041.Product was discarded on site.Manufacturer response for cranial access kit, neurosciences cranial access kit (per site reporter).Representative notified directly by clinical site, complaint number (b)(4) opened.

• Brand Name: INTEGRA CRANIAL ACCESS KIT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 14828207
• MDR Text Key: 294769987
• Report Number: 14828207
• Device Sequence Number: 1
• Product Code: HBG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS7280
• Device Lot Number: W2109041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1