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

Catalog Number	H02706
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Dental clamp broke during set up.
Additional Manufacturer Narrative
Investigation results: no product was returned.No date code mentioned.Batch number indicates 2 years old.Why did the clamp break? the clamp broke due to the inability of the material to withstand the stresses being applied.Why? 1) the clamp is old and broke due to the expected life of usage.2) the customer has exposed the clamp to chemicals known to cause stress crack corrosion or has not rinsed it off before autoclaving.3) customer is not aware that overextending clamps is detrimental to the "spring" material of the clamp and decreases the life expectancy.4) no other issues have come up for this batch of clamps.5) customer is satisfied with the product credit/replacement and has not requested additional information.Attached photos exhibit dark discoloration on the entire surface of the clamp indicating possible caustic/acidic chemical usage.At the break, the black discoloration indicates the breaking was caused by chemical corrosion.Clamp was 2 years old and probably at the end of its life expectancy.Able (3 occurences from (b)(6) 2017 to (b)(6) 2018) capa required: no capa required.

• Brand Name: HYGENIC
• Common Device Name: DENTAL CLAMP
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7808439
• Report Number: 2416455-2018-08231
• Device Sequence Number: 19284837
• Product Code: EEF
• UDI-Device Identifier: D661H027060
• UDI-Public: D661H027060
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H02706
• Device Lot Number: G99527
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1