MAUDE Adverse Event Report: CARDINAL HEALTH 2.5MM DRILL BIT/QC/GOLD/110MM; 2.5 MM DRILL BIT

Model Number 310.25.EM

Device Problem Metal Shedding Debris (1804)

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

Event Date 05/27/2015

Event Type  malfunction  

Event Description

On may 27th, dr (b)(6) was using a 310.25em drill bit lot 000440 to drill soft bone in a (b)(6) female.He noticed metal debris coming from the drill site.He was able to flush the area to remove the shavings.No report of patient injury.

Manufacturer Narrative

The sample involved in this reported incident has not been released by the facility at this time.Multiple attempts to evaluate the device have been made and we have been informed that at this time they are unable to release the device.The device history record¿s (2) for lot 000440 were reviewed and no anomalies were uncovered.The material, material hardness, and processing steps were verified by the supplier, precision edge surgical products company llc.The product was manufactured to revision m.No action is required at this time.We will continue to monitor for any similar reports and take action if required.

• Brand Name: 2.5MM DRILL BIT/QC/GOLD/110MM
• Type of Device: 2.5 MM DRILL BIT
• Manufacturer (Section D): CARDINAL HEALTH; 720 s. colorado blvd; # 550-s; denver CO 80246
• Manufacturer (Section G): CARDINAL HEALTH; 720 s. colorado blvd.; #550-s; denver CO 80246
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 4879493
• MDR Text Key: 6060235
• Report Number: 1423537-2015-00045
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 310.25.EM
• Device Catalogue Number: 310.25.EM
• Device Lot Number: 000440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 44 YR