MAUDE Adverse Event Report: COLTENE WHALEDENT INC. HYGENIC GLOSS FINISH WINGED CLAMP #12A - SERRATED JAWED, UPPER LEFT MOLARS, 1 PC; DENTAL CLAMP

Model Number H02706

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Clamps were returned for investigation.The following date code was obtained from one of the clamps: rc - manufactured 2020 may/june.The other clamp only had 1 piece returned and it was not the piece with the date code on it.One clamp has rust on its surface visible to the naked eye.Both clamps were also examined under a microscope.The clamp that has visible rust is covered in a clear residue and many rust spots.There is also evidence of pitting on the clamps surface.The surface of the break has a spot of dark discoloration that extends across almost the entire surface.The other clamp is relatively clean but has some scratches on its surface.Its break surface also has a spot of dark discoloration that extends across almost the entire surface.The customer's cleaning process including equipment and solutions is unknown.However, the condition of the break surface of the clamps indicates that the customer likely used an acidic or caustic solution in their cleaning process which was able to corrosively penetrate the material.Use of a corrosive cleaning solution can cause the degradation of the material of the clamp.The residue on the clamp further indicates that the customer likely has poor rinsing practices.When poor rinsing practices are coupled with a corrosive solution and autoclave sterilization, degradation of the material is typical and accelerated.It is most likely that the degradation of the material of the clamp caused the breakage.Clamps undergo an amount of stress when they are expanded under normal use.Degradation of the material causes them to be weaker and unable to withstand the force of expansion.To prevent degradation of the material, clamps needs to be cleaned with a ph neutral solution and to be rinsed properly with water after cleaning.De-ionized is preferable for rinsing as tap water may contain harsh alkaline chemicals (chlorides) added to kill bacteria.Also, do not let clamps get scratched by clamps or other instruments.Scratching the surface removes the outer passivated layer of the clamp, making it more susceptible to corrosion.Root cause: break caused by material degradation.

Event Description

The clamps broke during treatment.The clamp was first tried on by clamping it onto the tooth with the forceps.Then the rubber dam clamp was attached to the patient's tooth with the dental dam and the dental dam frame was used.During the treatment the clamp suddenly broke and jumped out of the mouth of the patient, the dental dam came off the tooth and saliva entered the tooth.There was no injury to the user; however, saliva got into the trepanned tooth.Due to the saliva intrusion, the treatment had to be started all over again, including re-draining and the additional working time.Otherwise, no further measures had to be taken.

• Brand Name: HYGENIC GLOSS FINISH WINGED CLAMP #12A - SERRATED JAWED, UPPER LEFT MOLARS, 1 PC
• Type of Device: DENTAL CLAMP
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer (Section G): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer Contact: tricia cregger ; 235 ascot parkway; cuyahoga falls, OH 44223 ; 3309168904
• MDR Report Key: 11254458
• MDR Text Key: 229584061
• Report Number: 2416455-2021-00001
• Device Sequence Number: 1
• Product Code: EEF
• UDI-Device Identifier: D661H027060
• UDI-Public: D661H027060
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H02706
• Device Catalogue Number: H02706
• Device Lot Number: K08500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention