MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.2MM TAPER SIDE CUTTING CARBIDE BUR; BUR, DENTAL

Catalog Number 1607002105

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.

Event Description

It was reported that during a surgical procedure, it was noted that when the nurse opened the pack, the tip of the bur was broken.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported the procedure was completed successfully.

Manufacturer Narrative

Investigation results indicate that the most likely cause of the bur break was due to a handling error which resulted in the bur experiencing a high force causing the bur to break in the pack.A review of the label, #1607-002-748 rev.D, the label indicates by way of an expandable label #0036-724-000 rev.P has the following icon "do not use if package is damaged".

Event Description

It was reported that during a surgical procedure, it was noted that when the nurse opened the pack, the tip of the bur was broken.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported the procedure was completed successfully.

• Brand Name: 1.2MM TAPER SIDE CUTTING 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: 7189263
• MDR Text Key: 97408936
• Report Number: 0001811755-2018-00051
• Device Sequence Number: 1
• Product Code: EJL
• UDI-Device Identifier: 4546540030337
• UDI-Public: (01)4546540030337
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

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: 1607002105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/15/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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