MAUDE Adverse Event Report: COLTENE WHALEDENT INC. HYGENIC; DENTAL CLAMP

Model Number H01049

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 06/18/2018

Event Type  malfunction  

Event Description

After putting the dental clamp on tooth the clamp popped out of mouth and injured patient.

Manufacturer Narrative

The issue was reported to be, b2 clamp after putting it on the tooth in minutes jumped in my face and injured my patient.Upon further investigation it was found that the clamp broke in the patient's mouth and caused a small cut.Product was not returned, however several pictures were provided.The pictures do not show the clamp date code nor was a batch number provided, so it is unknown when the clamp was manufactured.From the pictures, the clamp appears to be tarnished and has residue on the surface.The surface of the break specifically looks black.This suggests that the cleaning solution used is harmful to the metal and that the clamps are not getting properly rinsed after cleaning.It was determined that the customer uses unodent enzymatic ultrasonic economy refill to clean the clamp.This cleaning solution contains didecyldimethyl ammonium chloride, which is caustic.The residue on the clamp suggests it was not being rinsed properly.Improper rinsing after using a caustic cleaning solution leaves the caustic solution on the surface which leads to degradation of the metal.The black color on the surface of the break indicates the presence of caustic stress corrosion (csc), which is the most probable cause of the clamp breakage.To prevent csc, the clamps need to be rinsed with water after cleaning de-ionized is preferable as tap water may contain harsh alkaline chemicals (chlorides) added to kill bacteria.Insufficient rinsing after using caustic chemicals in the cleaning process prior to autoclave sterilization will significantly increase the chance of premature breakage as the heat from the autoclave will speed up the degradation process.This is the only complaint for this part number in the past 12 months.Risk assessment: probability: improbable.Severity: serious.Risk: minimal residual risk.Capa required: no.

• Brand Name: HYGENIC
• Type of Device: DENTAL CLAMP
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7800496
• MDR Text Key: 118094109
• Report Number: 2416455-2018-00002
• 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,health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H01049
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1