MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE IMPACTION DRILL; DRIVER, WIRE, AND BONE DRILL, MANUAL

Catalog Number 5400300000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility an oil substance was seen in the plug area of the core impaction drill.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.

Manufacturer Narrative

The reported event was duplicated.During functional inspection the service technician noted a wet substance down in the connection socket.The presence of fluid inside a device can potentially be caused by improper or non-recommended cleaning procedures.The device was serviced for preventive maintenance and returned to the user facility.

• Brand Name: CORE IMPACTION DRILL
• Type of Device: DRIVER, WIRE, AND BONE DRILL, MANUAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3832892
• MDR Text Key: 16448966
• Report Number: 0001811755-2014-01926
• Device Sequence Number: 1
• Product Code: DZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5400300000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2014
• Date Manufacturer Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1