MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO EGG/OVAL SHAPED CARBIDE BUR; BUR, DENTAL

Catalog Number 0277010062

Device Problem Break (1069)

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

Event Date 05/05/2014

Event Type  malfunction  

Event Description

It was reported via a medwatch form that the bur broke during a procedure.There was no report of adverse consequences or surgical delay as a result of this event.

Event Description

It was reported via a medwatch form that the bur broke during a procedure.There was no report of adverse consequences or surgical delay as a result of this event.

Manufacturer Narrative

The device is available for return.A follow up report will be filed once the quality investigation is complete.Device not yet returned to manufacturer.

Manufacturer Narrative

The device was not returned for evaluation.The quality investigation is complete.Device not returned to the manufacturer.

• Brand Name: EGG/OVAL SHAPED CARBIDE BUR
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 4000909
• MDR Text Key: 4707045
• Report Number: 0001811755-2014-02838
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0277010062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 08/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1