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

Catalog Number V040252025040

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

It was reported that reciproc files broke.Reported that broken part remained in root canal, tooth was not yet filled as of (b)(6) 2021.Next treatment is planned (b)(6) 2021 if tooth is without pain.Tooth will be filled, if not will be extricated or root end surgery is planned.Patient has new appointment (b)(6) 2021.

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.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.Additionally.Of this report no new information on patient outcome of follow up treatment; once information of outcome becomes available it will be submitted when it becomes available.

Manufacturer Narrative

Involved product broken during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhrs review (batches #1632661 and #1631963).The two unused reciproc blue files r40 6/100 25mm 040 which were returned were evaluated and were found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.

• 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: 12934780
• MDR Text Key: 285462907
• Report Number: 9611053-2021-00427
• Device Sequence Number: 1
• Product Code: EKS
• 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: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V040252025040
• Device Lot Number: 319443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/16/2021
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 11/16/2021
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1