Catalog Number H01050 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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This complaint is for material h01050 b 3 hyg tissue retractor.No batch information was provided so an inventory analysis cannot be performed.The 3 clamps were returned for investigation, however half of one clamp was not returned.The clamps have a date codes of rb (manufactured 2020 mar/apr) and pc (manufactured 2019 may/jun).The third clamp's date code is unknown as it is on the piece that was not returned.The clamps were examined under a microscope.The surface of all clamps is covered in white residue and small crystal-like debris.The surface is also pitted and has small rust spots.Each break surface has rust spots and one had an area of black discoloration.The customer's cleaning process including equipment and solutions is unknown.However, the condition of the break surface indicates that the customer likely used a solution in their cleaning process which was able to corrosively penetrate the material.The black coloration indicates that the ph of the cleaning solution was too low (acidic).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.Root cause: break caused by material degradation.
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Search Alerts/Recalls
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