MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM; STEREOTAXY

Catalog Number CRWPRECISE

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned device verified the customer information as valid.Only the guide block and the crw arch system pointer were received; not the complete crw precision arc system.The guide block and crw arch system pointer did not match.They needed to be replaced.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.Linked to mfg report number: 3004608878-2020-00331.

Event Description

This is 2 of 2 reports.It was reported that when using the newly delivered crwprecise crw precision arc system for the first time, the pointer could not be inserted into the guideblock.There was no patient contact or injury.The issue was discovered during surgery; the patient was already in the operating room.The event lead to a significant increase in surgery time of 1 hour.The surgery was completed with a second existing system.

• Brand Name: CRW PRECISION ARC SYSTEM
• Type of Device: STEREOTAXY
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10280829
• MDR Text Key: 203314431
• Report Number: 3004608878-2020-00332
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRWPRECISE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1