MAUDE Adverse Event Report: COLTENE WHALEDENT INC. ALPEN; CARBIDE BUR

Catalog Number R100245

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2018

Event Type  malfunction  

Event Description

Carbide bur broke during procedure.

Manufacturer Narrative

Customer states they received (2) alpen carbide 245 fg 10 pks (r100245), lot number i19416.The customer claims that the carbide burs are breaking during the procedure.The customer did not return the product for investigation.Complaint investigation: complaint history analysis shows no additional complaints of breaking for this batch.Inventory analysis shows no remaining product in stock of this lot number.Sap shows stock of this batch, containing 250 packs of carbide burs, was depleted 12/29/2017.Per the risk file for carbide dental burs, (90693-004), breaking could have been caused by: bur is used multiple times.Bur dulls and cuts poorly.Extra force is applied to bur to compensate for reduced cutting performance.Bur breaks during use due to contact with foreign object; such as, a post.Incorrect bur used for application.Bur is used at unintended angle/stresses.Because the product was never returned for investigation, the complaint cannot be confirmed.Root cause analysis: why? customer states the carbide burs are breaking during the procedure.Why? customer is dissatisfied with the material strength of the burs.Why? customer expectations do not meet final delivered product quality.Why? see possibilities listed above.Per the risk file for carbide dental burs (90693-004), the severity would be minor if sharp bur contacts the patient at a high speed and patient experiences minor abrasion (bur is recovered before aspiration or ingestion).The severity would be serious if the patient ingests the bur or aspirates the bur causing pain, discomfort, infection, and surgical intervention.The customer did not specify if the bur was ingested or aspirated.Capa assessment: no capa is required at this time.This is an isolated event.This lot will continue to be monitored for further occurrences.

• Brand Name: ALPEN
• Type of Device: CARBIDE BUR
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7808580
• MDR Text Key: 118246601
• Report Number: 2416455-2018-08235
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R100245
• Device Lot Number: I19416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1