MAUDE Adverse Event Report: HERAEUS KULZER, LLC IVORY CLAMP; CLAMP, RUBBER DAM

Catalog Number 50057304

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.This malfunction is reportable as sec.803.50 states: if you are a manufacturer, you must report to us no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.The malfunction will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.Distorting the clamp during usage causing breakage of the clamp.Device breakage is addressed in the directions for use.The directions state, "do not place clamp in mouth until the rubber dam has been properly placed.Clamp could become a choking or safety hazard if dropped or broken in the mouth without proper use of the rubber dam at all times." the directions for use warns, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage." the user used the clamp in a manner that is contraindicated.The clamp had been severely torqued and severely hyperextended, leading to metal fatigue.

Event Description

This complaint is from (b)(6).Dealer returned clamp with note: broken clamp.

• Brand Name: IVORY CLAMP
• Type of Device: CLAMP, RUBBER DAM
• Manufacturer (Section D): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer (Section G): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 5732079
• MDR Text Key: 48779435
• Report Number: 1821514-2016-00016
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 50057304
• Device Lot Number: C4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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