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

Catalog Number H02705

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2018

Event Type  malfunction  

Event Description

Clamp broke after two uses.Clamp was drenched in multisept plus.Clean clamp was sterilized by autoclaving at 134 degrees.

Manufacturer Narrative

Customer complaint: clamp broke after two uses.Clamp was drenched in multisept plus.Clean clamp was sterilized by autoclaving at 134 degrees.Clamp purchased 25/04/2018.Customer was requested by kg customer services to return the broken clamp to inc but product has not been returned to date.Customer did provide photos of the clamps at the point of breakage.These photos are beneficial in determining the root cause of the complaint.See attached "customer email including photos".All photos indicate the clamps are glossy and appear to be new.The first/third photo shows an area of dark discoloration partially on the face of the break on both pieces and a large dark area on the inside of the radius.The discoloration on the face of the break is on the inside radius and would affect the clamp in the extended position.This is an indication that the solution used in the cleaning process has affected the chemical composition of the stainless steel and is most likely a caustic stress corrosion.The safety data sheet (sds) ph value of multisept plus in concentrate form is 11.5 - 13.0.(highly caustic).The sds for multisept plus states the ph of a 2% solution is 10.5 - 11.5.This is still a caustic solution.The ifu specifies to use neutral ph solutions for the cleaning of this clamp.Customer stated that the clamps were drenched in multisept plus solution.No further details of the cleaning process were provided.If a caustic solution must be used, there are important steps that need to be followed closely in the process when using caustic solutions as a cleaning agent for clamps: 1) concentration and contact times for the immersion bath must be accurate.Longer times and higher concentrations may clean better, but the exposure to the material is detrimental to the stainless steel (especially stainless steel clamps that have been tempered to make them flexible for functional operation).2) rinse thoroughly with a distilled water or de-ionized water to completely remove the caustic chemicals in the solution from the surface prior to autoclaving.If the caustic solution remains on the surface of the clamp, the higher temperature in the sterilization process will accelerate the corrosion effect and the integrity of the material will deteriorate faster.12a and 13a clamps are most susceptible to break since they have largest difference in the relaxed state to the fully extended state.There have been four reported h02705 (13a) clamps break in the last 12 months.Three of the four clamp complaints that have broken were initiated in europe.A total of (b)(4) clamps were manufactured on batch h77566 on 4/17/2017.Inventory was depleted on 6/21/2017.No other reported complaints have been received for this batch at this time.This is isolated to one clamp for one customer.

• Brand Name: HYGENIC
• Type of Device: DENTAL DAM CLAMP
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7796687
• MDR Text Key: 117852002
• Report Number: 2416455-2018-00006
• 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: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H02705
• Device Lot Number: H77566
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1