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

Model Number IVORY CLAMP SS W8A WNGLSS MOLAR

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

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.Device not returned to manufacturer.

Event Description

By way of dealer rep from (b)(4), complaint that clamp broke on first use.The office used a competitor's brand forceps.

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.Item evaluated: ivory clamp ss w8a wnglss molar, lot no.: c3, manufacture date: 7/2013, receipt date: 4/01/2016.Complaint: broke on first use.Evaluation summary: two pieces of the clamp were received for analysis.Returned with the broken pieces was a clamp bag of a different, younger lot number.The clamp broke in the right hole area, looking down on the bow with claws to the front.With pieces reassembled with a smooth seam, overextension and torquing are apparent.When compared to standard samples, the overextension is obvious.The da also stated they used premier forceps.The dfu states, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage." cause of breakage: misuse by user due to damage by overextension.Conclusion: the complaint is not confirmed due to user misuse.Due to the aforementioned fact that this was customer misuse, no further action is deemed necessary at this time.The investigation is closed.Capa measures are not proposed or initiated.

Event Description

By way of dealer rep from (b)(4), complaint that clamp broke on first use.The office used a competitor's brand forceps.

• 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: 5519631
• MDR Text Key: 40960502
• Report Number: 1821514-2016-00010
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Dental Assistant
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Expiration Date: 01/28/2019
• Device Model Number: IVORY CLAMP SS W8A WNGLSS MOLAR
• Device Catalogue Number: 50057536
• Device Lot Number: C3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: 1 YR
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• 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