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

Catalog Number H01050

Device Problem Fracture (1260)

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

Event Date 01/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 the customer stated the following: clamp breaks in the patient's mouth under rubber dam so there is no debris in the mouth.It is a fracture at the level of the arch of the clamp.The metal deforms and breaks after one or two uses.These incidents are numerous for b2 a little less b3 almost never b1.The metal does not resist the clamp pliers which open the clamp before positioning on the tooth.And it breaks during the treatment a little after putting it on.At this time, the field also leaves.The session must be stopped.Take another clamp and start over.The additional information provided states that there was no patient or user injury.The dental dam came off the tooth when the clamp broke, and all pieces of the clamp were retrieved.

Manufacturer Narrative

The complaint is for material h01050 b 3 hyg tissue retractor, qty 2.The batch number that is attached to the complaint is j91168.Inventory analysis shows no remaining product in stock of this batch number.Sap shows the stock of this batch of 1000 was depleted on 3/31/2021.Two clamps were returned for investigation.One clamp contained a date code pc (manufactured 2019 may/june), while the other clamp contained the date code pd (manufactured 2019 july/august).The clamp with a date code pc broke to the right of the hygienic logo.The clamp contains a few spots of white residue on the top and bottom of the clamp band visible to the naked eye.The clamp was examined under a microscope where a rust spot along the edge of the break surface near the underside of the clamp band was visible.The rust spot extended into the break surface.The clamp with a date code pd broke on the right side of the clamp where the face and the clamp band meet.The clamp contains a substantial amount of white residue on the underside of the clamp visible to the naked eye.The clamp was examined under a microscope where a rust spot along the edge of the break surface on the underside of the clamp band became visible.The rust spot extended slightly into the break surface.The customer's complaint is confirmed.The customer's cleaning process including equipment and solutions is unknown.However, the condition of the break surfaces indicate that the customer likely used a 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 clamps further indicate 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 clamps 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 need 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.Root cause: break caused by material degradation.

• Brand Name: HYGENIC
• Type of Device: DENTAL DAM 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
• MDR Report Key: 13549322
• MDR Text Key: 286875067
• Report Number: 2416455-2022-00004
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: H01050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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