MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL WAVEONE GOLD GLIDER 015-02/21MM BLISTER 6; FILE, PULP CANAL, ENDODONTIC

Catalog Number	BSTW1GG621015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional 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 has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that waveone gold glider 015-02/21mm blister 6 broke during use.The dentist no longer has the information about the exact circumstances of this event and if the parts have been retrieved or not.Reportedly, no injury occurred.
Additional Manufacturer Narrative
Summary: returned waveone gold primary file 25mm was analyzed and turns out to be not broken, not damaged.No fault was found.For information, no unused file is available for evaluation.Moreover, the batch nothing unusual to report was found during dhr review (batch #1835784).

• Brand Name: WAVEONE GOLD GLIDER 015-02/21MM BLISTER 6
• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19220336
• Report Number: 8031010-2024-00046
• Device Sequence Number: 18192313
• Product Code: EKS
• UDI-Device Identifier: D716TSTW1GG3210151
• UDI-Public: D716TSTW1GG3210151
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: BSTW1GG621015
• Device Lot Number: 1835784
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown