MAUDE Adverse Event Report: COLTENE WHALEDENT INC FIESTA; DENTAL CLAMP

Catalog Number H09964

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 03/26/2018

Event Type  malfunction  

Event Description

A dental clamp broke in the patients mouth during use.

Manufacturer Narrative

Investigation: this complaint is for material number h09964, batch h73731.The clamp has a date code of lf this code corresponds to a manufacturing date of november/december 2016.Inventory analysis shows no remaining product in stock of this batch number.Sap shows the stock of this batch of 975 was depleted on 6/26/2017.Complaint history was reviewed there have been 11 other complaints for this issue for this material number in the past 12 months.There has been one other complaint involving batch h73731.Only two other complaints mentioned the date code of lf.Photos were provided for investigation of the issue.The photos show no obvious discoloration or corrosion on the clamp.The break occurred at one end of the clamp.Clamp does not appear to be deformed in shape.Photos do not show the surface of the break.Further root cause analysis cannot be performed as no physical product was returned.From the photos provided it is unclear what caused the clamp break.Root cause: since root cause is inconclusive from the photos, there are several possible root causes of the clamp breakage: 1.Customer uses a caustic cleaning solution causing corrosion of the clamp.(corrosion may be present and may need to be viewed with a microscope).2.Clamp was not rinsed properly after being cleaned with a caustic solution and heat from autoclaving sped up material degradation.3.Customer overextended the clamp.4.Clamp had internal material defect.5.Customer applied an excessive point force on the clamp.6.Heat treating issue caused the clamp material to be brittle.Capa required: a capa has already been opened for this issue refer to capa cs062218.Complaints will continue to be monitored for additional instances.

• Brand Name: FIESTA
• Type of Device: DENTAL CLAMP
• Manufacturer (Section D): COLTENE WHALEDENT INC; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7793930
• MDR Text Key: 117837995
• Report Number: 2416455-2018-00001
• Device Sequence Number: 1
• Product Code: EEF
• 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: foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H09964
• Device Lot Number: H73731
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1