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

Catalog Number 5400300000

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2014

Event Type  malfunction  

Event Description

It was reported that during testing prior to a procedure at the user facility the core impaction drill was overheating.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.It was also reported that during testing conducted at the manufacturer facility the core impaction drill had an unknown substance coating the nose cone.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported with this event.

Event Description

It was reported that during testing prior to a procedure at the user facility, the core impaction drill was overheating.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.It was also reported that during testing conducted at the manufacturer facility, the core impaction drill had an unknown substance coating the nose cone.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported with this event.

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Manufacturer Narrative

The technician was unable to duplicate the reported events but noted that the rotor was affected by a substance.

• 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: 3752852
• MDR Text Key: 4421334
• Report Number: 0001811755-2014-01342
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5400300000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2007
• 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