MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRANIAL ACCESS KIT W/O DRUGS; CRANIAL ACCESS KITS (CAK)

Catalog Number 826616

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the hand drill of the cranial access kit was "cracking" while trying to drill during a bedside ventriculostomy procedure.The provider was using the hand crank drill to drill a hole into the patient¿s bone to place a catheter and the pa heard/felt an internal crack.The procedure was completed with a replacement product.No patient injury reported.

Manufacturer Narrative

Unique device identifier (udi)- (b)(4).The cranial access kit was returned for evaluation: device history record (dhr) - no anomalies occurred at the time of manufacture of the hand drill itself, or during the assembly of the kit at final kitting.Failure analysis- the returned unit was found to work as intended, and met all acceptance criteria.Three returned units were tested using the testing media for inspection with both bits which come standard in the cranial access kits.Additionally, it was confirmed that the gearing ratio was performing as intended.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

• Brand Name: CRANIAL ACCESS KIT W/O DRUGS
• Type of Device: CRANIAL ACCESS KITS (CAK)
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10289220
• MDR Text Key: 203489848
• Report Number: 1226348-2020-00412
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 826616
• Device Lot Number: 19DDA792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1