MAUDE Adverse Event Report: VDW GMBH RECIPROC BLUE FILES, 6X, STERILE; FILE, PULP CANAL, ENDODONTIC

Catalog Number V040252021025

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.Dentist no longer wants to complain, she will watch it.If it happens again she will contact us.No product will be sent in for investigation.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.Additional information regarding the patient outcome from treatment has been requested and will be submitted as it becomes available.

Event Description

It was reported that 2 reciproc blue files broke in 2 different patients.This case is for the 2nd patient, broken parts remained in root canal for the 2nd patient.Treatment for 2nd patient is scheduled for (b)(6) 2021.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.

Event Description

Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: RECIPROC BLUE FILES, 6X, STERILE
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer (Section G): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 12953514
• MDR Text Key: 283398496
• Report Number: 9611053-2021-00429
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V040252021025
• Device Lot Number: 362611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/19/2021
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1