MAUDE Adverse Event Report: INTEGRA YORK, PA INC EXTR FCPS, GRIP DEEP 151; M51 - GENERAL DENTISTRY

Catalog Number DEFDG151

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Tooth Fracture (2428)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

Customer initially reports the device was not working properly.On (b)(6) 2014, doctor reports the device broke the tooth off because of uneven grip at the base of the tooth.Doctor had to cut the tooth out, no harm to pt, no excess bleeding.Event occurred in april or may.No other info available.

Manufacturer Narrative

Integra has completed their internal investigation: methods: eval of actual device.Review of device history records.Review of complaint history.Results: investigation results: the returned forceps showing wear, discoloration, and staining.The forceps grip area appears to have minimal corrosion.The complaint is a customer preference issue the end user does not prefer the design of the forceps.Forceps dimensions are within specifications.The complaint is unconfirmed.Dhr review was completed with all history available variance authorization/deviation history: none.There is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: none.Health hazard eval history: none.Trend analysis: 2 complaints of this nature were identified.Conclusion: there were two extracting forceps, manufactured in december 2007, returned in used condition.Forceps dimensions are within specifications.The complaint is unconfirmed.Integra considers this complaint closed.Future incidents of this nature will be documented for recurrence and trending purposes.

• Brand Name: EXTR FCPS, GRIP DEEP 151
• Type of Device: M51 - GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise dr; 6099366828
• MDR Report Key: 4093174
• MDR Text Key: 4759071
• Report Number: 2523190-2014-00055
• Device Sequence Number: 1
• Product Code: EMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DEFDG151
• Device Lot Number: 00266578
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1