MAUDE Adverse Event Report: CARB.B.SURGERY ZEKRYA FG 28MM; BUR, DENTAL

Catalog Number E015135100000

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Per condition #1 of exemption e2006004, events meeting the definition of a serious injury are required to be reported.Therefore, because of the separated piece will be removed surgically, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a carbide bur fractured during use.A surgery is planned under general anesthesia to remove the broken piece.

Manufacturer Narrative

The returned carbide burs surgery zekrya fg 28mm have been analyzed.One bur has been used but is not damaged.The other bur is actually broken in the carbide portion.No material defect was found during analysis of the rupture pattern.Nothing unusual to report was found during dhr review (batch #1524669).Customer specified that the burs were used with a speed rotation of 400.000rpm.According maillefer recommendations, a speed rotation of 300.000rpm should not be exceeded for this type of instrument which has a diameter of 0.8mm.The root cause is improper use/maint/service.

• Brand Name: CARB.B.SURGERY ZEKRYA FG 28MM
• Type of Device: BUR, DENTAL
• MDR Report Key: 10428686
• MDR Text Key: 203651457
• Report Number: 8031010-2020-00153
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

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: E015135100000
• Device Lot Number: 1524669
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability