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 Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when a surgeon was drilling to make a small hole a lower jaw bone, the tip of the bur broke.It was also reported that the tip was found on x-ray after suturing the patient.It was further reported that the patient had a second surgery to remove the broken fragment and the procedure was completed successfully.

Manufacturer Narrative

Investigation results indicate that excessive force while cutting caused the bur to fracture.A review of the label for the bur indicates the following; "do not use excessive force".The associated devices ifu for use with j-notch burs were reviewed and contain the following warning; "do not apply excessive pressure, such as bending or prying, with a cutting accessory to prevent fracturing the accessory.".

Event Description

It was reported that when a surgeon was drilling to make a small hole a lower jaw bone, the tip of the bur broke.It was also reported that the tip was found on x-ray after suturing the patient.It was further reported that the patient had a second surgery to remove the broken fragment and 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: 7276389
• MDR Text Key: 100253414
• Report Number: 0001811755-2018-00420
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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 Catalogue Number: 1607002105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 03/16/2018
• 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
• Patient Outcome(s): Required Intervention