MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CROSS-CUT FISSURE BUR, TAPERED"; BUR, DENTAL

Catalog Number 2296101221

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.Evaluation in progress.

Event Description

It was reported that during a surgical procedure, six burs broke.It was also reported that the procedure was delayed while new burs were prepared, the length of the delay was not greater than 30 minutes.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

Manufacturer Narrative

Upon evaluation of the returned burs, five burs were for part number 2296101221, one bur has an unknown part number.This mdr report is for the 5 broken burs which broke during this event.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a surgical procedure, six burs broke.It was also reported that the procedure was delayed while new burs were prepared, the length of the delay was not greater than 30 minutes.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.Upon evaluation of the returned burs, five burs were for part number 2296101221, one bur has an unknown part number.This mdr report is for the 5 broken burs which broke during this event.

Manufacturer Narrative

The product reported involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The device was sent to the product engineering group (r&d) who concluded that both brasseler and meisinger were contacted that supply 2 piece carbide burs, both suppliers use a silver brazing process and complete in house testing, therefore the returned parts did not come from these suppliers.These are the only suppliers from what stryker receives this style of 2 piece carbide and sst burs.The account did not send back the heads of the broken samples to confirm part number.Therefore we cannot confirm that these parts came from stryker, from the results of this analysis it is concluded that these are not stryker burs.

Event Description

It was reported that during a surgical procedure, six burs broke.It was also reported that the procedure was delayed while new burs were prepared, the length of the delay was not greater than 30 minutes.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.Upon evaluation of the returned burs, five burs were for part number 2296101221, one bur has an unknown part number.This mdr report is for the 5 broken burs which broke during this event.

• Brand Name: CROSS-CUT FISSURE BUR, TAPERED"
• 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: 5456418
• MDR Text Key: 38867893
• Report Number: 0001811755-2016-00234
• 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,Followup
• Report Date: 04/07/2017

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 Expiration Date: 01/01/2020
• Device Catalogue Number: 2296101221
• Device Lot Number: 15007017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/15/2016; 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2015
• 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