MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0MM OVAL CARBIDE BUR; BUR, DENTAL

Catalog Number 2296101026

Device Problem Break (1069)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device not returned for evaluation.

Event Description

It was reported via a medwatch report ((b)(4)), that during an mandibular osteotomy sagittal split procedure, the bur broke.It was also reported that an x-ray was taken to locate and retrieve the broken bit.It was further reported there was a delay of 30 to 45 minutes as a result of this event.It was also reported that a back-up bur was readily available to complete the procedure.

Manufacturer Narrative

The quality investigation is complete.

Event Description

It was reported via a medwatch report (reference 4900240000-2016-8036), that during an mandibular osteotomy sagittal split procedure, the bur broke.It was also reported that an x-ray was taken to locate and retrieve the broken bit.It was further reported there was a delay of 30 to 45 minutes as a result of this event.It was also reported that a back-up bur was readily available to complete the procedure.

• Brand Name: 4.0MM OVAL 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 5857238
• MDR Text Key: 51495278
• Report Number: 0001811755-2016-01752
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 2296101026
• Device Lot Number: 16096017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: 06/23/2017
• Supplement Dates FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• 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